Back to resultsPivotal Study of a Percutaneous Mitral Valve Repair System (EVERESTIIRCT)
Primary Purpose
Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous mitral valve repair using MitraClip implant
Mitral valve repair or replacement surgery
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Valve Insufficiency focused on measuring Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation, Mitral Insufficiency, Mitral Valve, MR, Mitral Valve Prolapse, Edge to Edge (E2E), Alfieri Technique, MitraClip, Functional MR, Degenerative MR, Echocardiogram, CAD - Coronary Artery Disease, Heart Failure, Heart Attack, EVEREST, EVEREST I, EVEREST II, REALISM
Eligibility Criteria
Key Inclusion/Exclusion Criteria: Patients with Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation (MR) based on American Society of Echocardiography guidelines: Are 18 years or older. Symptomatic If asymptomatic, must have new onset of atrial fibrillation, pulmonary hypertension, or evidence of left ventricular dysfunction Are candidates for mitral valve surgery Are candidates for transseptal catheterization Primary regurgitant jet must originate from malcoaptation of the A2 and P2 scallops of the mitral valve Appropriate valve anatomy for MitraClip Does not need other cardiac surgery or any emergency surgery Did not experience myocardial infarction in prior 12 weeks or endovascular procedure in prior 30 days Mitral valve orifice area ≥ 4 cm2 Do not have renal insufficiency Echocardiographic evidence of intracardiac mass, thrombus or vegetation
Sites / Locations
- Evanston Northwestern Healthcare
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Percutaneous mitral valve repair using MitraClip implant. The calculated sample size was 186 patients in the device arm
Mitral valve repair or replacement surgery. The calculated sample size was 93 patients in the control arm.
Outcomes
Primary Outcome Measures
Number of Participants With Major Adverse Events (MAE)
Defined as a combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastrointestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).
Secondary Outcome Measures
Freedom From All-Cause Mortality
Freedom From All-Cause Mortality
Freedom From All-Cause Mortality
Freedom From All-Cause Mortality
Freedom From All-Cause Mortality
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation.
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR) in Intention to Treat Strategy Cohort
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory.
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory.
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory.
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory.
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory.
Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV)
Left Ventricular Status includes Left ventricular (LV) end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.
Left Ventricular Status- LVEDV, LVESV
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV),as determined by the core echo laboratory at 12 months.
Left Ventricular Status- LVEDV, LVESV
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 24 months.
Left Ventricular Status- LVEDV, LVESV
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 3 years.
Left Ventricular Status- LVEDV, LVESV
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 4 years
Left Ventricular Status- LVEDV, LVESV
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 5 years.
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory.
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 12 months.
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 24 months.
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 3 years.
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 4 years.
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 5 years.
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Short Form (SF)-36 Quality of Life Questionnaire.
The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) & mental health status (Mental Component Score) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.
The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively.
Short Form (SF)-36 Quality of Life Questionnaire.
The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) & mental health status (Mental Component Score) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.
The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively.
Cardiac Output
Cardiac output as measured by core lab echocardiography.
Cardiac Output
Cardiac output as measured by core lab echocardiography.
Cardiac Output
Cardiac output as measured by core lab echocardiography.
Cardiac Index
Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.
Cardiac Index (CI)
Defined as cardiac output divided by body surface area as measured by core lab echocardiography. CI is a normalization of cardiac output to take into account the effect of body size on cardiac output requirements.
Cardiac Index
Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.
Regurgitant Volume
Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Regurgitant Volume
Regurgitant volume as determined by the core echo laboratory.
Regurgitant Volume
Regurgitant volume as determined by the core echo laboratory.
Regurgitant Fraction (RF)
RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
Regurgitant Fraction
Regurgitant fraction is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
Regurgitant Fraction
Regurgitant fraction is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
Number of Participants With Clip Implant Rate
Defined as the rate of successful implantation of MitraClip(s).
Number of Participants With Acute Procedural Success
Defined as successful MitraClip implantation with resulting MR of 2+ or less.
Number of Participants With Acute Surgical Success
Defined as successful mitral valve repair or replacement surgery.
Number of Participants With Successful Clip Implant and Acute Procedural Success
Acute procedural success is defined as MR severity ≤ 2 at discharge or 1 grade MR reduction at discharge accompanied by 1 level NYHA reduction.
Number of Participants With Mitral Valve Repair Success.
Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.
Number of Participants With Mitral Valve Repair Success.
Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.
Number of Participants With Procedural Freedom From In-hospital MAE.
Number of Participants With Procedural Freedom From In-hospital MAE
Number of Participants With MAE: Surgery After Device and First Time Surgery Control
Number of Participants With Major Vascular Complications
Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer:
Hematoma at access site >6 cm;
Retroperitoneal hematoma;
Arteriovenous (AV) fistula;
Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting >48 hours;
Vascular Surgical Repair at catheter access sites;
Pulmonary embolism;
Ipsilateral deep vein thrombus; or
Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.
Number of Participants With Major Vascular Complications
Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer:
Hematoma at access site >6 cm;
Retroperitoneal hematoma;
Arteriovenous (AV) fistula;
Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting >48 hours;
Vascular Surgical Repair at catheter access sites;
Pulmonary embolism;
Ipsilateral deep vein thrombus; or
Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.
Number of Participants With Major Bleeding Complications.
Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 30 days or hospital discharge, whichever is longer.
Number of Participants With Major Bleeding Complications.
Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 12 months.
Number of Participants With Major Adverse Events (MAE)
Number of Participants With MAE in Patients Over 75 Years of Age.
Number of Participants With MAE in Patients Over 75 Years of Age.
Number of Participants With Dysrhythmia
Number of Participants With Dysrhythmia
Number of Participants With Endocarditis.
Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.
Number of Participants With Endocarditis.
Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.
Number of Participants With Thrombosis.
Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.
Number of Participants With Thrombosis.
Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.
Number of Participants With Hemolysis
Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below:
Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding.
Minor: Does not require intervention.
Number of Participants With Hemolysis
Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below:
Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding.
Minor: Does not require intervention.
Number of Participants With Clinically Significant Atrial Septal Defect (ASD).
Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.
Number of Participants With Clinically Significant Atrial Septal Defect (ASD)
Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Mitral Valve Area by Planimetry Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Mitral Valve Area by Planimetry Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Mitral Valve Area by Planimetry Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Mitral Valve Area by Pressure Half-time Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Mitral Valve Area by Pressure Half-time Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Mitral Valve Area by Pressure Half-time Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Transvalvular Mitral Valve Gradient
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Defined as the mean pressure gradient across the mitral valve as measured by Echocardiography Core Laboratory (ECL).
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Post-procedure Length of Hospital Stay
Post-procedure Intensive Care Unit (ICU) / Critical Care Unit (CCU) Duration
Number of Participants With Hospital Re-admissions
Defined as re-admission to the hospital for any reason. The endpoint was intended to capture each time a patient was re-admitted to the hospital for any reason and was to be reported as a rate through 30 days for both the Device and Control groups.
Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility/Hospital
Number of Participants With Incidence of Hospital Readmissions for Congestive Heart Failure (CHF).
Number of Participants With New Coumadin (Warfarin) Usage
Number of Participants With New Coumadin (Warfarin) Usage
Number of Participants With Durability of the MitraClip Device and Surgery.
Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Number of Participants With Durability of the MitraClip Device and Surgery.
Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Number of Participants With Durability of the MitraClip Device and Surgery.
Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Number of Participants With Durability of the MitraClip Device and Surgery.
Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+
Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+
Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+
Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+
Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+
Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device.
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device
Number of Participants With Non-cerebral Thromboembolism.
Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe.
"Discharge" refers to each individual patient's date of hospital discharge. The discharge date varies for each patient, but in general, discharge occurs before 30-days follow-up. A 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or otherwise uninterpretable.
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Number of Participants With Non-cerebral Thromboembolism.
Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.
Number of Participants With Incidence of Mitral Valve Replacement
Number of Participants With Incidence of Mitral Valve Replacement
Full Information
NCT ID
NCT00209274
First Posted
September 13, 2005
Last Updated
November 5, 2018
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT00209274
Brief Title
Pivotal Study of a Percutaneous Mitral Valve Repair System
Acronym
EVERESTIIRCT
Official Title
Pivotal Study: A Study of the Evalve Cardiovascular Valve Repair System - Endovascular Valve Edge-to-Edge REpair STudy (EVERESTIIRCT)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery. The EVEREST II High Risk Registry (HRR) study is a prospective multi-center study of the MitraClip System for the treatment of mitral valve regurgitation in high surgical risk patients. Enrollment in the RCT and HRR is closed. A continued access prospective, multi-center study (REALISM) of the MitraClip System in a surgical population (non-high risk arm) and a high surgical risk population (high risk arm) is ongoing. Enrollment in the non-high risk arm of REALISM is closed. Enrollment in the high risk arm of REALISM is ongoing. Patients enrolled in EVEREST II undergo 30-day, 6-month, 12-month, 18-month and 24-month clinical and echocardiographic follow-up, and then annually for 5 years.
Detailed Description
Prospective, multi-center, randomized study of the safety and effectiveness of an endovascular approach to the treatment of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System (MitraClip® implant).
A minimum of 279 evaluable patients randomized 2:1 to MitraClip or mitral valve surgery, respectively, are required to test the primary safety and effectiveness endpoints of the RCT. Enrollment in the RCT is now complete. 60 roll-in patients were enrolled under EVEREST II RCT.
38 clinical sites throughout the US and Canada have participated in the RCT and HRR. 37 US sites are participating in REALISM.
The RCT is powered to test the hypothesis MitraClip has both superiority of safety and non-inferiority of effectiveness compared to mitral valve repair or replacement surgery. The HRR is powered to show lower mortality at 30 days with the MitraClip than predicted surgical mortality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation, Mitral Insufficiency
Keywords
Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation, Mitral Insufficiency, Mitral Valve, MR, Mitral Valve Prolapse, Edge to Edge (E2E), Alfieri Technique, MitraClip, Functional MR, Degenerative MR, Echocardiogram, CAD - Coronary Artery Disease, Heart Failure, Heart Attack, EVEREST, EVEREST I, EVEREST II, REALISM
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
279 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Percutaneous mitral valve repair using MitraClip implant. The calculated sample size was 186 patients in the device arm
Arm Title
2
Arm Type
Active Comparator
Arm Description
Mitral valve repair or replacement surgery. The calculated sample size was 93 patients in the control arm.
Intervention Type
Device
Intervention Name(s)
Percutaneous mitral valve repair using MitraClip implant
Other Intervention Name(s)
MitraClip
Intervention Description
MitraClip Implant
Intervention Type
Procedure
Intervention Name(s)
Mitral valve repair or replacement surgery
Intervention Description
Repair or replacement of mitral valve
Primary Outcome Measure Information:
Title
Number of Participants With Major Adverse Events (MAE)
Description
Defined as a combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastrointestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.
Time Frame
30 days
Title
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Freedom From All-Cause Mortality
Time Frame
12 months
Title
Freedom From All-Cause Mortality
Time Frame
24 months
Title
Freedom From All-Cause Mortality
Time Frame
3 years
Title
Freedom From All-Cause Mortality
Time Frame
4 years
Title
Freedom From All-Cause Mortality
Time Frame
5 years
Title
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation.
Time Frame
12 months
Title
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).
Time Frame
24 months
Title
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR) in Intention to Treat Strategy Cohort
Time Frame
24 months
Title
Left Ventricular Ejection Fraction (LVEF)
Description
LVEF as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.
Time Frame
At discharge (≤ 14 days following index procedure) or 30 days
Title
Left Ventricular Ejection Fraction (LVEF)
Description
LVEF as determined by the core echo laboratory.
Time Frame
12 months
Title
Left Ventricular Ejection Fraction (LVEF)
Description
LVEF as determined by the core echo laboratory.
Time Frame
24 months
Title
Left Ventricular Ejection Fraction (LVEF)
Description
LVEF as determined by the core echo laboratory.
Time Frame
3 years
Title
Left Ventricular Ejection Fraction (LVEF)
Description
LVEF as determined by the core echo laboratory.
Time Frame
4 years
Title
Left Ventricular Ejection Fraction (LVEF)
Description
LVEF as determined by the core echo laboratory.
Time Frame
5 years
Title
Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV)
Description
Left Ventricular Status includes Left ventricular (LV) end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.
Time Frame
30 days
Title
Left Ventricular Status- LVEDV, LVESV
Description
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV),as determined by the core echo laboratory at 12 months.
Time Frame
12 months
Title
Left Ventricular Status- LVEDV, LVESV
Description
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 24 months.
Time Frame
24 months
Title
Left Ventricular Status- LVEDV, LVESV
Description
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 3 years.
Time Frame
3 years
Title
Left Ventricular Status- LVEDV, LVESV
Description
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 4 years
Time Frame
4 years
Title
Left Ventricular Status- LVEDV, LVESV
Description
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 5 years.
Time Frame
5 years
Title
Left Ventricular Internal Dimension Systole (LVIDs)
Description
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time Frame
30 days
Title
Left Ventricular Internal Dimension Systole (LVIDs)
Description
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time Frame
12 months
Title
Left Ventricular Internal Dimension Systole (LVIDs)
Description
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time Frame
2 years
Title
Left Ventricular Internal Dimension Systole (LVIDs)
Description
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time Frame
3 years
Title
Left Ventricular Internal Dimension Systole (LVIDs)
Description
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time Frame
4 years
Title
Left Ventricular Internal Dimension Systole (LVIDs)
Description
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time Frame
5 years
Title
Left Ventricular Internal Dimension Diastole (LVIDd)
Description
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory.
Time Frame
30 days
Title
Left Ventricular Internal Dimension Diastole (LVIDd)
Description
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 12 months.
Time Frame
12 months
Title
Left Ventricular Internal Dimension Diastole (LVIDd)
Description
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 24 months.
Time Frame
24 months
Title
Left Ventricular Internal Dimension Diastole (LVIDd)
Description
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 3 years.
Time Frame
3 years
Title
Left Ventricular Internal Dimension Diastole (LVIDd)
Description
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 4 years.
Time Frame
4 years
Title
Left Ventricular Internal Dimension Diastole (LVIDd)
Description
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 5 years.
Time Frame
5 years
Title
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Description
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
Baseline
Title
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Description
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
30 days
Title
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Description
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
12 months
Title
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Description
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
24 months
Title
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Description
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
3 years
Title
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Description
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
4 years
Title
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Description
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
5 years
Title
New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
Description
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
30 days
Title
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
Description
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
12 months
Title
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
Description
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
2 years
Title
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
Description
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
3 years
Title
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
Description
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
4 years
Title
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
Description
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
5 years
Title
Short Form (SF)-36 Quality of Life Questionnaire.
Description
The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) & mental health status (Mental Component Score) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.
The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively.
Time Frame
30 days
Title
Short Form (SF)-36 Quality of Life Questionnaire.
Description
The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) & mental health status (Mental Component Score) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.
The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively.
Time Frame
12 months
Title
Cardiac Output
Description
Cardiac output as measured by core lab echocardiography.
Time Frame
30 days
Title
Cardiac Output
Description
Cardiac output as measured by core lab echocardiography.
Time Frame
12 months
Title
Cardiac Output
Description
Cardiac output as measured by core lab echocardiography.
Time Frame
24 months
Title
Cardiac Index
Description
Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.
Time Frame
30 days
Title
Cardiac Index (CI)
Description
Defined as cardiac output divided by body surface area as measured by core lab echocardiography. CI is a normalization of cardiac output to take into account the effect of body size on cardiac output requirements.
Time Frame
12 months
Title
Cardiac Index
Description
Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.
Time Frame
24 months
Title
Regurgitant Volume
Description
Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Time Frame
30 Days
Title
Regurgitant Volume
Description
Regurgitant volume as determined by the core echo laboratory.
Time Frame
12 months
Title
Regurgitant Volume
Description
Regurgitant volume as determined by the core echo laboratory.
Time Frame
24 months
Title
Regurgitant Fraction (RF)
Description
RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
Time Frame
30 Days
Title
Regurgitant Fraction
Description
Regurgitant fraction is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
Time Frame
12 months
Title
Regurgitant Fraction
Description
Regurgitant fraction is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
Time Frame
24 months
Title
Number of Participants With Clip Implant Rate
Description
Defined as the rate of successful implantation of MitraClip(s).
Time Frame
Day 0
Title
Number of Participants With Acute Procedural Success
Description
Defined as successful MitraClip implantation with resulting MR of 2+ or less.
Time Frame
30 Days
Title
Number of Participants With Acute Surgical Success
Description
Defined as successful mitral valve repair or replacement surgery.
Time Frame
30 Days
Title
Number of Participants With Successful Clip Implant and Acute Procedural Success
Description
Acute procedural success is defined as MR severity ≤ 2 at discharge or 1 grade MR reduction at discharge accompanied by 1 level NYHA reduction.
Time Frame
30 days
Title
Number of Participants With Mitral Valve Repair Success.
Description
Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.
Time Frame
12 months
Title
Number of Participants With Mitral Valve Repair Success.
Description
Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.
Time Frame
24 months
Title
Number of Participants With Procedural Freedom From In-hospital MAE.
Time Frame
Day 0
Title
Number of Participants With Procedural Freedom From In-hospital MAE
Time Frame
Day 30
Title
Number of Participants With MAE: Surgery After Device and First Time Surgery Control
Time Frame
30 days
Title
Number of Participants With Major Vascular Complications
Description
Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer:
Hematoma at access site >6 cm;
Retroperitoneal hematoma;
Arteriovenous (AV) fistula;
Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting >48 hours;
Vascular Surgical Repair at catheter access sites;
Pulmonary embolism;
Ipsilateral deep vein thrombus; or
Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.
Time Frame
30 days
Title
Number of Participants With Major Vascular Complications
Description
Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer:
Hematoma at access site >6 cm;
Retroperitoneal hematoma;
Arteriovenous (AV) fistula;
Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting >48 hours;
Vascular Surgical Repair at catheter access sites;
Pulmonary embolism;
Ipsilateral deep vein thrombus; or
Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.
Time Frame
12 months
Title
Number of Participants With Major Bleeding Complications.
Description
Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 30 days or hospital discharge, whichever is longer.
Time Frame
30 days
Title
Number of Participants With Major Bleeding Complications.
Description
Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 12 months.
Time Frame
12 months
Title
Number of Participants With Major Adverse Events (MAE)
Time Frame
12 months.
Title
Number of Participants With MAE in Patients Over 75 Years of Age.
Time Frame
30 days
Title
Number of Participants With MAE in Patients Over 75 Years of Age.
Time Frame
12 months
Title
Number of Participants With Dysrhythmia
Time Frame
30 days
Title
Number of Participants With Dysrhythmia
Time Frame
12 months
Title
Number of Participants With Endocarditis.
Description
Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.
Time Frame
30 days
Title
Number of Participants With Endocarditis.
Description
Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.
Time Frame
12 months
Title
Number of Participants With Thrombosis.
Description
Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.
Time Frame
30 days
Title
Number of Participants With Thrombosis.
Description
Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.
Time Frame
12 months
Title
Number of Participants With Hemolysis
Description
Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below:
Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding.
Minor: Does not require intervention.
Time Frame
30 days
Title
Number of Participants With Hemolysis
Description
Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below:
Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding.
Minor: Does not require intervention.
Time Frame
12 months
Title
Number of Participants With Clinically Significant Atrial Septal Defect (ASD).
Description
Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.
Time Frame
30 days
Title
Number of Participants With Clinically Significant Atrial Septal Defect (ASD)
Description
Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.
Time Frame
12 months
Title
Number of Participants With Mitral Valve Stenosis
Description
Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.
Time Frame
30 days
Title
Number of Participants With Mitral Valve Stenosis
Description
Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.
Time Frame
12 months
Title
Number of Participants With Mitral Valve Stenosis
Description
Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.
Time Frame
24 months
Title
Number of Participants With Mitral Valve Stenosis
Description
Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.
Time Frame
3 years
Title
Number of Participants With Mitral Valve Stenosis
Description
Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.
Time Frame
4 years
Title
Number of Participants With Mitral Valve Stenosis
Description
Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.
Time Frame
5 years
Title
Mitral Valve Area by Planimetry
Description
Mitral valve area as measured by core lab echocardiography.
Time Frame
At Discharge (≤14 days of index procedure)
Title
Mitral Valve Area by Planimetry
Description
Mitral valve area as measured by core lab echocardiography.
Time Frame
30 Days
Title
Mitral Valve Area by Planimetry
Description
Mitral valve area as measured by core lab echocardiography.
Time Frame
12 months
Title
Mitral Valve Area by Planimetry
Description
Mitral valve area as measured by core lab echocardiography.
Time Frame
24 months
Title
Mitral Valve Area by Planimetry
Description
Mitral valve area as measured by core lab echocardiography.
Time Frame
3 years
Title
Mitral Valve Area by Planimetry
Description
Mitral valve area as measured by core lab echocardiography.
Time Frame
4 years
Title
Mitral Valve Area by Planimetry
Description
Mitral valve area as measured by core lab echocardiography.
Time Frame
5 years
Title
Mitral Valve Area by Planimetry Index
Description
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Time Frame
30 Days
Title
Mitral Valve Area by Planimetry Index
Description
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Time Frame
12 months
Title
Mitral Valve Area by Planimetry Index
Description
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Time Frame
24 months
Title
Mitral Valve Area by Pressure Half-time
Description
Mitral valve area as measured by core lab echocardiography.
Time Frame
At Discharge (≤14 days of index procedure)
Title
Mitral Valve Area by Pressure Half-time
Description
Mitral valve area as measured by core lab echocardiography.
Time Frame
30 days
Title
Mitral Valve Area by Pressure Half-time
Description
Mitral valve area as measured by core lab echocardiography.
Time Frame
12 months
Title
Mitral Valve Area by Pressure Half-time
Description
Mitral valve area as measured by core lab echocardiography.
Time Frame
24 months
Title
Mitral Valve Area by Pressure Half-time
Description
Mitral valve area as measured by core lab echocardiography.
Time Frame
3 years
Title
Mitral Valve Area by Pressure Half-time
Description
Mitral valve area as measured by core lab echocardiography.
Time Frame
4 years
Title
Mitral Valve Area by Pressure Half-time
Description
Mitral valve area as measured by core lab echocardiography.
Time Frame
5 years
Title
Mitral Valve Area by Pressure Half-time Index
Description
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Time Frame
30 Days
Title
Mitral Valve Area by Pressure Half-time Index
Description
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Time Frame
12 months
Title
Mitral Valve Area by Pressure Half-time Index
Description
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Time Frame
24 months
Title
Transvalvular Mitral Valve Gradient
Description
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Time Frame
At Discharge (≤ 14 days following index procedure)
Title
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Description
Defined as the mean pressure gradient across the mitral valve as measured by Echocardiography Core Laboratory (ECL).
Time Frame
12 months
Title
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Description
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Time Frame
24 months
Title
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Description
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Time Frame
3 year
Title
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Description
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Time Frame
4 year
Title
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Description
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Time Frame
5 years
Title
Post-procedure Length of Hospital Stay
Time Frame
30 Days
Title
Post-procedure Intensive Care Unit (ICU) / Critical Care Unit (CCU) Duration
Time Frame
30 Days
Title
Number of Participants With Hospital Re-admissions
Description
Defined as re-admission to the hospital for any reason. The endpoint was intended to capture each time a patient was re-admitted to the hospital for any reason and was to be reported as a rate through 30 days for both the Device and Control groups.
Time Frame
30 days
Title
Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility/Hospital
Time Frame
30 Days
Title
Number of Participants With Incidence of Hospital Readmissions for Congestive Heart Failure (CHF).
Time Frame
30 days
Title
Number of Participants With New Coumadin (Warfarin) Usage
Time Frame
30 days
Title
Number of Participants With New Coumadin (Warfarin) Usage
Time Frame
12 months
Title
Number of Participants With Durability of the MitraClip Device and Surgery.
Description
Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Time Frame
12 months
Title
Number of Participants With Durability of the MitraClip Device and Surgery.
Description
Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Time Frame
12-18 months
Title
Number of Participants With Durability of the MitraClip Device and Surgery.
Description
Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Time Frame
18-24 months
Title
Number of Participants With Durability of the MitraClip Device and Surgery.
Description
Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Time Frame
24 months-3 year
Title
Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+
Description
Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+
Time Frame
12 months
Title
Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+
Description
Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+
Time Frame
24 months
Title
Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+
Description
Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+
Time Frame
3 years
Title
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Description
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Time Frame
12 months
Title
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Description
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Time Frame
24 months
Title
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Description
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Time Frame
3 years
Title
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Description
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Time Frame
4 years
Title
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Description
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Time Frame
5 years
Title
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Description
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Time Frame
12 months
Title
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Description
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Time Frame
24 months
Title
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Description
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Time Frame
3 years
Title
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Description
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Time Frame
4 years
Title
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Description
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Time Frame
5 years
Title
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Description
Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device.
Time Frame
12 months
Title
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Description
Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device
Time Frame
12 months to 3 years
Title
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Description
Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device
Time Frame
12 months to 4 years
Title
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Description
Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device
Time Frame
12 months to 5 years
Title
Number of Participants With Non-cerebral Thromboembolism.
Description
Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.
Time Frame
12 months
Title
Number of Participants With MR Severity
Description
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe.
"Discharge" refers to each individual patient's date of hospital discharge. The discharge date varies for each patient, but in general, discharge occurs before 30-days follow-up. A 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or otherwise uninterpretable.
Time Frame
30 days
Title
Number of Participants With MR Severity
Description
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Time Frame
12 months
Title
Number of Participants With MR Severity
Description
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Time Frame
24 months
Title
Number of Participants With MR Severity
Description
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Time Frame
3 years
Title
Number of Participants With MR Severity
Description
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Time Frame
4 years
Title
Number of Participants With MR Severity
Description
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Time Frame
5 years
Title
Number of Participants With Non-cerebral Thromboembolism.
Description
Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.
Time Frame
30 days
Title
Number of Participants With Incidence of Mitral Valve Replacement
Time Frame
12 months
Title
Number of Participants With Incidence of Mitral Valve Replacement
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion/Exclusion Criteria:
Patients with Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation (MR) based on American Society of Echocardiography guidelines:
Are 18 years or older.
Symptomatic
If asymptomatic, must have new onset of atrial fibrillation, pulmonary hypertension, or evidence of left ventricular dysfunction
Are candidates for mitral valve surgery
Are candidates for transseptal catheterization
Primary regurgitant jet must originate from malcoaptation of the A2 and P2 scallops of the mitral valve
Appropriate valve anatomy for MitraClip
Does not need other cardiac surgery or any emergency surgery
Did not experience myocardial infarction in prior 12 weeks or endovascular procedure in prior 30 days
Mitral valve orifice area ≥ 4 cm2
Do not have renal insufficiency
Echocardiographic evidence of intracardiac mass, thrombus or vegetation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ted Feldman, M.D.
Organizational Affiliation
NorthShore University HealthSystem
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Donald G Glower Jr., MD
Organizational Affiliation
Duke University Medical Center, Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evanston Northwestern Healthcare
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
12. IPD Sharing Statement
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Pivotal Study of a Percutaneous Mitral Valve Repair System
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