Back to resultsFeasibility Study of a Percutaneous Mitral Valve Repair System. (EVEREST(I))
Primary Purpose
Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Percutaneous mitral valve repair (MitraClip Implant)
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, E2E - Edge to Edge, Alfieri Technique, MitraClip, Functional MR, Degenerative MR, Echocardiogram, CAD - Coronary Artery Disease, Heart Failure, Heart Attack, EVEREST, EVEREST I, EVEREST II
Eligibility Criteria
Inclusion Criteria: Have moderate to severe mitral regurgitation, symptomatic or asymptomatic with evidence of left ventricular dysfunction; Experience regurgitation origination from the central two-thirds of the valve; Qualify as a candidate for mitral valve surgery including cardiopulmonary bypass. Exclusion Criteria: Ejection fraction < 30% Endocarditis Rheumatic heart disease Renal insufficiency
Sites / Locations
- Evanston Northwestern Healthcare
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MitraClip
Arm Description
Percutaneous mitral valve repair (MitraClip Implant)
Outcomes
Primary Outcome Measures
Mitral Regurgitation Severity
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Mitral Regurgitation Severity
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Mitral Regurgitation Severity
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Mitral Regurgitation Severity
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Mitral Regurgitation Severity
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Mitral Regurgitation Severity
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Mitral Regurgitation Severity
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Major Adverse Events (MAE)
Defined in the Protocol as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed MitraClip device, single leaflet device attachment, stroke and septicemia.
Major Adverse Events (MAE)
Defined in the Protocol as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed MitraClip device, single leaflet device attachment, stroke and septicemia.
Secondary Outcome Measures
Procedure Time
Procedure Time, defined as the time of start of the transseptal procedure to the time the Steerable Guide Catheter (SOC) is removed, averaged 255 minutes, or just over 4 hours.
The reported Procedure Time includes the time required to collect Protocol required hemodynamic data pre- and post-implantation of the MitraClip device.
Device Time
Device Time, defined as the time of insertion of the Steerable Guide Catheter (SGC) to the time the MitraClip Delivery Catheter is retracted into the SGC.
Contrast Volume
Mean contrast volume utilized during the MitraClip procedure.
Fluoroscopy Duration
Mean fluoroscopy duration during the MitraClip procedure.
Number of Mitraclip Devices Implanted
Intra-procedural Major Adverse Events
Significant intra-procedural Major adverse events are defined as Major Adverse Events that occurred on the day of the procedure
Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration
Post-procedure Hospital Stay
Second Intervention to Place a Second MitraClip Device
MitraClip Device Embolizations and Single Leaflet Device Attachment
MitraClip device embolizations means the detachment from both mitral leaflets. Single Leaflet Device Attachment (SLDA) is defined as the attachment of a single leaflet to the MitraClip device.
Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)
Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.
Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)
Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.
Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)
Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.
Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)
Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.
Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)
Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.
Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)
Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.
Death (Kaplan-Meier Freedom From Death)
Death (Kaplan-Meier Freedom From Death)
Death (Kaplan-Meier Freedom From Death)
Death (Kaplan-Meier Freedom From Death)
Death (Kaplan-Meier Freedom From Death)
Death (Kaplan-Meier Freedom From Death)
Major Vascular and Bleeding Complications
Major bleeding complications is defined as transfusion of >=2 units of blood due to bleeding related to the index procedure
Major Vascular and Bleeding Complications
Major bleeding complications is defined as transfusion of >=2 units of blood due to bleeding related to the index procedure
Other Secondary Safety Events
Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major).
Other Secondary Safety Events
Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major).
Left Ventricular End Diastolic Volume
Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Diastolic Volume
Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Diastolic Volume
Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Diastolic Volume
Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Diastolic Volume
Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Systolic Volume
Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Systolic Volume
Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Systolic Volume
Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Systolic Volume
Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Systolic Volume
Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Mitral Valve Area - Single Orifice
Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.
Mitral Valve Area - Single Orifice
Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.
Mitral Valve Area - Single Orifice
Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.
Mitral Valve Area - Single Orifice
Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.
Mitral Valve Area - Single Orifice
Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.
Mitral Valve Area (MVA) by Pressure Half-Time
The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.
The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography.
Mitral Valve Area (MVA) by Pressure Half-Time
The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.
The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT
PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography.
Mitral Valve Area (MVA) by Pressure Half-Time
The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.
The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography.
Mitral Valve Area (MVA) by Pressure Half-Time
The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.
The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography.
Mitral Valve Area (MVA) by Pressure Half-Time
The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.
The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography.
Mitral Valve Gradient
Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.
Mitral Valve Gradient
Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.
Mitral Valve Gradient
Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.
Mitral Valve Gradient
Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.
Mitral Valve Gradient
Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.
Cardiac Output
Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.
Cardiac Output
Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.
Cardiac Output
Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.
Cardiac Output
Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.
Cardiac Output
Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.
Cardiac Index
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.
Cardiac Index
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.
Cardiac Index
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.
Cardiac Index
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.
Cardiac Index
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.
New York Heart Association (NYHA) Functional Class
Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
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
Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
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
Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
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
Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
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
Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
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
Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
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
Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
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
Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
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
Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
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.
Full Information
NCT ID
NCT00209339
First Posted
September 13, 2005
Last Updated
November 5, 2018
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT00209339
Brief Title
Feasibility Study of a Percutaneous Mitral Valve Repair System.
Acronym
EVEREST(I)
Official Title
A Study of the Evalve Cardiovascular Valve Repair System Endovascular Valve Edge-to-Edge REpair STudy (EVEREST I).
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.
Detailed Description
Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System.
The study is a prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. A minimum of 20 patients will be enrolled (an additional maximum of 12 roll in-patients, a maximum of 2 per site, may be enrolled and analyzed separately). Patients will undergo 30-day, 6 month and 12 month clinical follow-up.
Up to 12 clinical sites throughout the US may participate.
The primary endpoint is acute safety at thirty days, with a secondary efficacy endpoint of reduction of MR.
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, E2E - Edge to Edge, Alfieri Technique, MitraClip, Functional MR, Degenerative MR, Echocardiogram, CAD - Coronary Artery Disease, Heart Failure, Heart Attack, EVEREST, EVEREST I, EVEREST II
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MitraClip
Arm Type
Experimental
Arm Description
Percutaneous mitral valve repair (MitraClip Implant)
Intervention Type
Device
Intervention Name(s)
Percutaneous mitral valve repair (MitraClip Implant)
Other Intervention Name(s)
EVEREST I, MitraClip
Intervention Description
Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
Primary Outcome Measure Information:
Title
Mitral Regurgitation Severity
Description
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Time Frame
At baseline
Title
Mitral Regurgitation Severity
Description
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Time Frame
At discharge or within 30 days of the procedure
Title
Mitral Regurgitation Severity
Description
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Time Frame
At 12 months
Title
Mitral Regurgitation Severity
Description
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Time Frame
At 24 months
Title
Mitral Regurgitation Severity
Description
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Time Frame
At 3 years
Title
Mitral Regurgitation Severity
Description
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Time Frame
At 4 years
Title
Mitral Regurgitation Severity
Description
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Time Frame
At 5 years
Title
Major Adverse Events (MAE)
Description
Defined in the Protocol as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed MitraClip device, single leaflet device attachment, stroke and septicemia.
Time Frame
Through 30 days
Title
Major Adverse Events (MAE)
Description
Defined in the Protocol as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed MitraClip device, single leaflet device attachment, stroke and septicemia.
Time Frame
Through 6 Months
Secondary Outcome Measure Information:
Title
Procedure Time
Description
Procedure Time, defined as the time of start of the transseptal procedure to the time the Steerable Guide Catheter (SOC) is removed, averaged 255 minutes, or just over 4 hours.
The reported Procedure Time includes the time required to collect Protocol required hemodynamic data pre- and post-implantation of the MitraClip device.
Time Frame
At day 0 (on the day of index procedure)
Title
Device Time
Description
Device Time, defined as the time of insertion of the Steerable Guide Catheter (SGC) to the time the MitraClip Delivery Catheter is retracted into the SGC.
Time Frame
At day 0 (on the day of index procedure)
Title
Contrast Volume
Description
Mean contrast volume utilized during the MitraClip procedure.
Time Frame
At day 0 (on the day of index procedure)
Title
Fluoroscopy Duration
Description
Mean fluoroscopy duration during the MitraClip procedure.
Time Frame
At day 0 (on the day of index procedure)
Title
Number of Mitraclip Devices Implanted
Time Frame
At day 0 (on the day of index procedure)
Title
Intra-procedural Major Adverse Events
Description
Significant intra-procedural Major adverse events are defined as Major Adverse Events that occurred on the day of the procedure
Time Frame
At day 0 (on the day of index procedure)
Title
Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration
Time Frame
Post index procedure within 30 days
Title
Post-procedure Hospital Stay
Time Frame
Post-index procedure until hospital discharge (1 to 19 days)
Title
Second Intervention to Place a Second MitraClip Device
Time Frame
Post index procedure through 5 years
Title
MitraClip Device Embolizations and Single Leaflet Device Attachment
Description
MitraClip device embolizations means the detachment from both mitral leaflets. Single Leaflet Device Attachment (SLDA) is defined as the attachment of a single leaflet to the MitraClip device.
Time Frame
Post index procedure through 5 years
Title
Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)
Description
Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.
Time Frame
At baseline
Title
Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)
Description
Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.
Time Frame
At 12 months
Title
Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)
Description
Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.
Time Frame
At 24 months
Title
Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)
Description
Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.
Time Frame
At 3 Years
Title
Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)
Description
Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.
Time Frame
At 4 Years
Title
Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)
Description
Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.
Time Frame
At 5 Years
Title
Death (Kaplan-Meier Freedom From Death)
Time Frame
Within 30 days of the procedure
Title
Death (Kaplan-Meier Freedom From Death)
Time Frame
At 12 months
Title
Death (Kaplan-Meier Freedom From Death)
Time Frame
At 24 months
Title
Death (Kaplan-Meier Freedom From Death)
Time Frame
At 3 years
Title
Death (Kaplan-Meier Freedom From Death)
Time Frame
At 4 years
Title
Death (Kaplan-Meier Freedom From Death)
Time Frame
At 5 years
Title
Major Vascular and Bleeding Complications
Description
Major bleeding complications is defined as transfusion of >=2 units of blood due to bleeding related to the index procedure
Time Frame
Through 30 days
Title
Major Vascular and Bleeding Complications
Description
Major bleeding complications is defined as transfusion of >=2 units of blood due to bleeding related to the index procedure
Time Frame
Through 6 Months
Title
Other Secondary Safety Events
Description
Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major).
Time Frame
Through 30 days
Title
Other Secondary Safety Events
Description
Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major).
Time Frame
Through 6 months
Title
Left Ventricular End Diastolic Volume
Description
Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Time Frame
Baseline
Title
Left Ventricular End Diastolic Volume
Description
Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Time Frame
During the hospital stay with a maximum of 3 days post index procedure (Discharge)
Title
Left Ventricular End Diastolic Volume
Description
Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Time Frame
12 months
Title
Left Ventricular End Diastolic Volume
Description
Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Time Frame
24 months
Title
Left Ventricular End Diastolic Volume
Description
Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Time Frame
60 months
Title
Left Ventricular End Systolic Volume
Description
Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Time Frame
Baseline
Title
Left Ventricular End Systolic Volume
Description
Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Time Frame
During the hospital stay with a maximum of 3 days post index procedure (Discharge)
Title
Left Ventricular End Systolic Volume
Description
Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Time Frame
12 months
Title
Left Ventricular End Systolic Volume
Description
Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Time Frame
24 months
Title
Left Ventricular End Systolic Volume
Description
Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Time Frame
60 months
Title
Mitral Valve Area - Single Orifice
Description
Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.
Time Frame
Baseline
Title
Mitral Valve Area - Single Orifice
Description
Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.
Time Frame
During the hospital stay with a maximum of 3 days post index procedure (Discharge)
Title
Mitral Valve Area - Single Orifice
Description
Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.
Time Frame
12 months
Title
Mitral Valve Area - Single Orifice
Description
Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.
Time Frame
24 months
Title
Mitral Valve Area - Single Orifice
Description
Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.
Time Frame
60 months
Title
Mitral Valve Area (MVA) by Pressure Half-Time
Description
The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.
The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography.
Time Frame
Baseline
Title
Mitral Valve Area (MVA) by Pressure Half-Time
Description
The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.
The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT
PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography.
Time Frame
During the hospital stay with a maximum of 3 days post index procedure (Discharge)
Title
Mitral Valve Area (MVA) by Pressure Half-Time
Description
The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.
The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography.
Time Frame
12 months
Title
Mitral Valve Area (MVA) by Pressure Half-Time
Description
The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.
The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography.
Time Frame
24 months
Title
Mitral Valve Area (MVA) by Pressure Half-Time
Description
The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.
The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography.
Time Frame
60 months
Title
Mitral Valve Gradient
Description
Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.
Time Frame
Baseline
Title
Mitral Valve Gradient
Description
Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.
Time Frame
During the hospital stay with a maximum of 3 days post index procedure (Discharge)
Title
Mitral Valve Gradient
Description
Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.
Time Frame
12 months
Title
Mitral Valve Gradient
Description
Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.
Time Frame
24 months
Title
Mitral Valve Gradient
Description
Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.
Time Frame
60 months
Title
Cardiac Output
Description
Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.
Time Frame
Baseline
Title
Cardiac Output
Description
Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.
Time Frame
During the hospital stay with a maximum of 3 days post index procedure (Discharge)
Title
Cardiac Output
Description
Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.
Time Frame
12 months
Title
Cardiac Output
Description
Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.
Time Frame
24 months
Title
Cardiac Output
Description
Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.
Time Frame
60 months
Title
Cardiac Index
Description
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.
Time Frame
Baseline
Title
Cardiac Index
Description
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.
Time Frame
During the hospital stay with a maximum of 3 days post index procedure (Discharge)
Title
Cardiac Index
Description
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.
Time Frame
12 months
Title
Cardiac Index
Description
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.
Time Frame
24 months
Title
Cardiac Index
Description
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.
Time Frame
60 months
Title
New York Heart Association (NYHA) Functional Class
Description
Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
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
New York Heart Association (NYHA) Functional Class
Description
Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
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
6 months
Title
New York Heart Association (NYHA) Functional Class
Description
Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
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
New York Heart Association (NYHA) Functional Class
Description
Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
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
New York Heart Association (NYHA) Functional Class
Description
Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
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
18 months
Title
New York Heart Association (NYHA) Functional Class
Description
Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
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
New York Heart Association (NYHA) Functional Class
Description
Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
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
36 months
Title
New York Heart Association (NYHA) Functional Class
Description
Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
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
48 months
Title
New York Heart Association (NYHA) Functional Class
Description
Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
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
60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have moderate to severe mitral regurgitation, symptomatic or asymptomatic with evidence of left ventricular dysfunction;
Experience regurgitation origination from the central two-thirds of the valve;
Qualify as a candidate for mitral valve surgery including cardiopulmonary bypass.
Exclusion Criteria:
Ejection fraction < 30%
Endocarditis
Rheumatic heart disease
Renal insufficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ted Feldman, M.D.
Organizational Affiliation
NorthShore University HealthSystem
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
Citations:
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14530193
Citation
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Lim DS, Kunjummen BJ, Smalling R. Mitral valve repair with the MitraClip device after prior surgical mitral annuloplasty. Catheter Cardiovasc Interv. 2010 Sep 1;76(3):455-9. doi: 10.1002/ccd.22547.
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Ciobanu A, Bennett S, Azam M, Clark A, Vinereanu D. Incremental value of three-dimensional transoesophageal echocardiography for guiding double percutaneous MitraClip (R) implantation in a 'no option' patient. Eur J Echocardiogr. 2011 Feb;12(2):E11. doi: 10.1093/ejechocard/jeq118. Epub 2010 Sep 27.
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Borgia F, Di Mario C, Franzen O. Adenosine-induced asystole to facilitate MitraClip placement in a patient with adverse mitral valve morphology. Heart. 2011 May;97(10):864. doi: 10.1136/hrt.2010.208132. Epub 2010 Oct 29. No abstract available.
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Feldman T, Kar S, Rinaldi M, Fail P, Hermiller J, Smalling R, Whitlow PL, Gray W, Low R, Herrmann HC, Lim S, Foster E, Glower D; EVEREST Investigators. Percutaneous mitral repair with the MitraClip system: safety and midterm durability in the initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) cohort. J Am Coll Cardiol. 2009 Aug 18;54(8):686-94. doi: 10.1016/j.jacc.2009.03.077.
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Foster E, Kwan D, Feldman T, Weissman NJ, Grayburn PA, Schwartz A, Rogers JH, Kar S, Rinaldi MJ, Fail PS, Hermiller J, Whitlow PL, Herrmann HC, Lim DS, Glower DD; EVEREST Investigators. Percutaneous mitral valve repair in the initial EVEREST cohort: evidence of reverse left ventricular remodeling. Circ Cardiovasc Imaging. 2013 Jul;6(4):522-30. doi: 10.1161/CIRCIMAGING.112.000098. Epub 2013 Apr 30.
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Feasibility Study of a Percutaneous Mitral Valve Repair System.
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