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Real World Expanded Multicenter Study of the MitraClip® System (REALISM) (REALISM)

Primary Purpose

Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MitraClip® implant

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, Mitral Regurgitation (MR), Mitral Valve Prolapse, Edge to Edge (E2E), Alfieri Technique, MitraClip, Functional MR, Degenerative MR, Echocardiogram, Coronary Artery Disease (CAD), Heart Failure, Heart Attack, EVEREST, EVEREST I, EVEREST II, REALISM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the mitral valve (MV)
Male or non-pregnant female
Trans-septal catheterization is determined to be feasible by the treating physician

High Risk Arm:

Predicted procedural mortality risk calculated using the STS surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a HR surgical candidate due to the presence of one of the following indications:
1. Porcelain aorta or mobile ascending aortic atheroma
2. Post-radiation mediastinum
3. Previous mediastinitis
4. Functional MR with EF <40
5. Over 75 years old with EF<40
6. Re-operation with patent grafts
7. Two or more prior chest surgeries
8. Hepatic cirrhosis
9. Three or more of the following STS high risk factors 9.1 Creatinine >2.5 mg/dL 9.2 Prior chest surgery 9.3 Age over 75 9.4 EF<35
Symptomatic moderate to severe (3+) or severe (4+) chronic MR and in the judgment of the investigator intervention to reduce MR is likely to provide symptomatic relief for the patient
American Society of Anesthesiologists (ASA) physical status classification of ASA IV or lower

Non-High Risk Arm:

Moderate to severe (3+) or severe (4+) chronic MV regurgitation and:
1. Symptomatic with >25% LVEF and LVESD ≤55mm or, 2. Asymptomatic with one or more of the following: i. Left Ventricular Ejection Fraction (LVEF) 25% to 60% ii. Left Ventricular End-Systolic Diameter (LVESD) ≥40 mm iii. New onset of Atrial fibrillation (AFib) iv. Pulmonary arterial systolic pressure (PASP) >50 mmHg at rest or >60 mmHg with exercise
Candidate for MV repair or replacement surgery, including cardiopulmonary bypass

Key Exclusion Criteria:

Evidence of an Acute Myocardial Infarction (AMI) in the prior 12 weeks of the intended treatment
In the judgment of the Investigator, the femoral vein cannot accommodate a 24 French scale (F) catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral Deep Venous Thrombus (DVT) is present
MV orifice area <4.0 cm2
If leaflet flail is present:
1. Flail Width ≥15 mm, or
2. Flail Gap ≥10 mm.
If leaflet tethering is present:
1. Vertical coaptation length <2 mm
Leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in MR. This may include:
1. Evidence of calcification in the grasping area of the A2 and/or P2 scallops
2. Presence of a significant cleft of A2 or P2 scallops
3. More than one anatomic criteria dimensionally near the exclusion limits
4. Bileaflet flail or severe bileaflet prolapse
5. Lack of both primary and secondary chordal support
Hemodynamic instability (systolic pressure <90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump).
Need for emergency surgery for any reason
Prior MV surgery or valvuloplasty or any currently implanted mechanical prosthetic valve or currently implanted Ventricular assist device (VAD)
Echocardiographic evidence of intracardiac mass, thrombus or vegetation
Active endocarditis or active rheumatic heart disease or leaflets degenerated from either endocarditis or rheumatic disease (i.e. noncompliant, perforated)
History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions
Life expectancy <12 months
Active infections requiring current antibiotic therapy
Patients in whom transesophageal echocardiography (TEE) is contraindicated

High Risk Arm:

EF <20%, and/or LVESD >60 mm

Non-High Risk Arm:

The need for any other cardiac surgery
Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure
Severe Left Ventricular (LV) dysfunction (EF <25% and/or LVESD >55mm)
Severe mitral annular calcification
Systolic anterior motion of the MV leaflet
Hypertrophic cardiomyopathy
History of a stroke or documented Transient Ischemic Attack (TIA) within the prior 6 months
Upper GI bleeding within the prior 6 months
Platelet count <75,000 cells/mm³
Creatinine >2.5mg/dL

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Non-High Risk

High Risk

Compassionate Use

Emergency Use

Arm Description

Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. This arm was evaluated as a separate study NCT00209274.

Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. This arm was evaluated as a separate study NCT01940120.

Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.

Outcomes

Primary Outcome Measures

Number of Participants With Major Adverse Events

A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastro-intestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.

Number of Participants With Major Adverse Events

A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.

Number of Participants With 12-Month Efficacy

Defined as freedom from: Surgery for Mitral Regurgitation (MR) or Valve Dysfunction, death, and MR > 2+ (moderate to severe (3+) or severe MR (4+)).

Secondary Outcome Measures

Number of Participants With Serious Adverse Events

The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization.

Number of Participants With Serious Adverse Events

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)

Number of Participants With Major Adverse Events (MAE) in Patients Over 75 Years of Age

MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.

Number of Participants With Major Adverse Events in Patients Over 75 Years of Age

Number of Participants With Acute Procedural Success

Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ or less as determined by the echocardiographic assessment at discharge. The 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or uninterpretable, providing the patient has not undergone subsequent surgery after attempted clip.

Number of Participants With Procedural Success

Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA at 30 days.

Number of Participants With Clinical Durability

Defined as the proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that at 12 months have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA at 12 months.

Number of Participants With Clip Implant Rate

Defined as the procedural rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.

Procedure Time

The mean procedure time is defined as the start time of the transseptal procedure to the time the steerable guide catheter (SGC) is removed.

Device Time

Device time is defined as the time of insertion of the Steerable Guide Catheter (SGC) to the time the MitraClip delivery catheter is retracted into the SGC.

Fluoroscopy Duration

Mean fluoroscopy duration during the MitraClip procedure.

Number of Participants With MitraClip Devices Implanted

The distribution of number of MitraClip devices implanted in patients.

Post-Procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU)/ Post-anesthesia Care Unit (PACU) Duration

Defined as the number of hours for which patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.

Post-Procedure Length of Hospital Stay

Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility.

Number of Participants Experiencing Death

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility

Number of Participants With Hospital Re-admissions

Defined as re-admission of patients to the hospital following discharge from the Clip procedure.

Number of Participants With Device Embolization or Single Leaflet Device Attachment (SLDA)

A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.

Number of Participants With Mitral Stenosis

Mitral stenosis is a key safety consideration assessed after implantation of the MitraClip device. It is defined as Mitral Valve Area (MVA) less than 1.5 cm^2 as assessed by the Echocardiography Core Laboratory (ECL).

Number of Participants With Mitral Regurgitation (MR) Severity

Paired site-assessed Mitral regurgitation severity between baseline and 30 days using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.

Number of Participants With MR Severity

Paired site-assessed Mitral regurgitation severity between baseline and 12 months using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.

Number of Participants With MR Severity

Paired site-assessed Mitral regurgitation severity between baseline and 2 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.

Number of Participants With MR Severity

Paired site-assessed Mitral regurgitation severity between baseline and 3 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.

Number of Participants With MR Severity

Paired site-assessed Mitral regurgitation severity between baseline and 4 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.

Number of Participants With MR Severity

Paired site-assessed Mitral regurgitation severity between baseline and 5 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.

Number of Participants With Second Intervention to Place an Additional Mitraclip Device.

If residual MR was determined to be clinically unacceptable for patients who received only 1 clip during the index procedure, a second intervention to place an additional MitraClip device could be considered.

Number of Participants With Second Intervention to Place an Additional Mitraclip Device.

Number of Participants With New York Heart Association (NYHA) Functional Class

Paired NYHA data from baseline to 30 days. 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 NYHA Functional Class

Paired NYHA data from baseline to 12 months. 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 NYHA Functional Class

Paired NYHA data from baseline to 2 years. 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 NYHA Functional Class

Paired NYHA data from baseline to 3 years. 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 NYHA Functional Class

Paired NYHA data from baseline to 4 years. 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 NYHA Functional Class

Paired NYHA data from baseline to 5 years. 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.

Left Ventricular End-diastolic Volume (LVEDV)

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to discharge or 30 days as determined by echo core laboratory.

Left Ventricular End-diastolic Volume (LVEDV)

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 12 months as determined by echo core laboratory.

Left Ventricular End-diastolic Volume (LVEDV)

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 24 months as determined by echo core laboratory.

Left Ventricular End-diastolic Volume (LVEDV)

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 36 months as determined by echo core laboratory.

Left Ventricular End-diastolic Volume (LVEDV)

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 48 months as determined by the echo core laboratory.

Left Ventricular End-diastolic Volume (LVEDV)

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 60 months as determined by echo core laboratory.

Left Ventricular End-systolic Volume (LVESV)

Paired Left ventricular end-systolic volume (LVESV) data from baseline to discharge or 30 days as determined by echo core laboratory.

Left Ventricular End-systolic Volume (LVESV)

Paired Left ventricular end-systolic volume (LVESV) data from baseline to 12 months as determined by echo core laboratory.

Left Ventricular End-systolic Volume (LVESV)

Paired Left ventricular end-systolic volume (LVESV) data from baseline to 24 months as determined by echo core laboratory.

Left Ventricular End-systolic Volume (LVESV)

Paired Left ventricular end-systolic volume (LVESV) data from baseline to 36 months as determined by echo core laboratory.

Left Ventricular End-systolic Volume (LVESV)

Paired Left ventricular end-systolic volume (LVESV) data from baseline to 48 months as determined by echo core laboratory.

Left Ventricular End-systolic Volume (LVESV)

Paired Left ventricular end-systolic volume (LVESV) data from baseline to 60 months as determined by echo core laboratory.

Left Ventricular Internal Dimension Diastole (LVIDd)

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to discharge or 30 days as determined by echo core laboratory.

Left Ventricular Internal Dimension Diastole (LVIDd)

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 12 months as determined by echo core laboratory.

Left Ventricular Internal Dimension Diastole (LVIDd)

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 24 months as determined by echo core laboratory.

Left Ventricular Internal Dimension Diastole (LVIDd)

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 36 months as determined by echo core laboratory.

Left Ventricular Internal Dimension Diastole (LVIDd)

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 48 months as determined by echo core laboratory.

Left Ventricular Internal Dimension Diastole (LVIDd)

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 60 months as determined by echo core laboratory.

Left Ventricular Internal Dimension Systole (LVIDs)

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to discharge or 30 days as determined by echo core laboratory.

Left Ventricular Internal Dimension Systole (LVIDs)

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 12 months as determined by echo core laboratory.

Left Ventricular Internal Dimension Systole (LVIDs)

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 24 months as determined by echo core laboratory.

Left Ventricular Internal Dimension Systole (LVIDs)

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 36 months as determined by echo core laboratory.

Left Ventricular Internal Dimension Systole (LVIDs)

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 48 months as determined by echo core laboratory.

Left Ventricular Internal Dimension Systole (LVIDs)

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 60 months as determined by echo core laboratory.

Left Ventricular Ejection Fraction (LVEF)

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to discharge or 30 days as determined by echo core laboratory.

Left Ventricular Ejection Fraction (LVEF)

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 12 months as determined by echo core laboratory.

Left Ventricular Ejection Fraction (LVEF)

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 24 months as determined by echo core laboratory.

Left Ventricular Ejection Fraction (LVEF)

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 36 months as determined by echo core laboratory.

Left Ventricular Ejection Fraction (LVEF)

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 48 months as determined by echo core laboratory.

Left Ventricular Ejection Fraction (LVEF)

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 60 months as determined by echo core laboratory.

Septal-Lateral Annular Dimension Diastole (SLADd)

Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to discharge or 30 days as determined by echo core laboratory.

Septal-Lateral Annular Dimension Diastole (SLADd)

Septal-Lateral Annular Dimension Systole (SLADs)

Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to discharge or 30 days as determined by echo core laboratory.

Septal-Lateral Annular Dimension Systole (SLADs)

Full Information

NCT ID

NCT01931956

First Posted

August 27, 2013

Last Updated

November 5, 2018

Sponsor

Abbott Medical Devices

1. Study Identification

Unique Protocol Identification Number

NCT01931956

Brief Title

Real World Expanded Multicenter Study of the MitraClip® System (REALISM)

Acronym

REALISM

Official Title

A Continued Access Registry of the Evalve® MitraClip® System: EVEREST II Real World Expanded Multicenter Study of the MitraClip System (REALISM)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

January 22, 2009 (Actual)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6-month, 12-month, 36-month and 60-month clinical follow-up. The study consists of two arms: a High Risk group (NCT01940120) and a Non-High Risk group (NCT00209274) . Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU).

Detailed Description

The EVEREST II REALISM study (REALISM study) is a continued access registry designed for continued data collection on the use of Abbott Vascular's MitraClip System (MitraClip® Device) under more "real world" conditions. After the completion of enrollment in the pivotal EVEREST II Randomized Controlled Trial (RCT) NCT00209274 and EVEREST II High Risk Registry Study NCT01940120, continued access to the technology was warranted to collect additional safety and effectiveness data on the MitraClip® Device. This continued access study was approved by FDA on November 21, 2008 (G030064). There are two arms (High Risk and Non-High Risk) in the REALISM study. Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). Enrollment in the Non-High Risk arm of the study concluded on April 14, 2011 and enrollment in the High Risk arm concluded on December 19, 2013. REALISM is a prospective, multi-center, 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). Patients with moderate-to-severe (3+) or severe (4+) mitral regurgitation (MR), as determined by the site from a transthoracic echocardiogram (TTE), were considered for enrollment in this study. The TTE and a transesophageal echocardiogram (TEE) are used to assess eligibility criteria for MR severity, valve anatomy and left ventricular parameters.

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, Mitral Regurgitation (MR), Mitral Valve Prolapse, Edge to Edge (E2E), Alfieri Technique, MitraClip, Functional MR, Degenerative MR, Echocardiogram, Coronary Artery Disease (CAD), Heart Failure, Heart Attack, EVEREST, EVEREST I, EVEREST II, REALISM

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

965 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Non-High Risk

Arm Type

Experimental

Arm Description

Arm Title

High Risk

Arm Type

Experimental

Arm Description

Arm Title

Compassionate Use

Arm Type

Experimental

Arm Description

Arm Title

Emergency Use

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

MitraClip® implant

Intervention Description

Percutaneous mitral valve repair using MitraClip implant

Primary Outcome Measure Information:

Title

Number of Participants With Major Adverse Events

Description

Time Frame

30 days

Title

Number of Participants With Major Adverse Events

Description

A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.

Time Frame

12 months

Title

Number of Participants With 12-Month Efficacy

Description

Defined as freedom from: Surgery for Mitral Regurgitation (MR) or Valve Dysfunction, death, and MR > 2+ (moderate to severe (3+) or severe MR (4+)).

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Number of Participants With Serious Adverse Events

Description

Time Frame

30 days

Title

Number of Participants With Serious Adverse Events

Description

Time Frame

12 months

Title

Number of Participants With Clinically Significant Atrial Septal Defect (ASD)

Description

Time Frame

30 days

Title

Number of Participants With Clinically Significant Atrial Septal Defect (ASD)

Description

Time Frame

12 months

Title

Number of Participants With Major Adverse Events (MAE) in Patients Over 75 Years of Age

Description

Time Frame

30 days

Title

Number of Participants With Major Adverse Events in Patients Over 75 Years of Age

Description

Time Frame

12 Months

Title

Number of Participants With Major Adverse Events in Patients Over 75 Years of Age

Description

Time Frame

2 years

Title

Number of Participants With Major Adverse Events in Patients Over 75 Years of Age

Description

Time Frame

3 years

Title

Number of Participants With Major Adverse Events in Patients Over 75 Years of Age

Description

Time Frame

4 years

Title

Number of Participants With Major Adverse Events in Patients Over 75 Years of Age

Description

Time Frame

5 years

Title

Number of Participants With Acute Procedural Success

Description

Time Frame

At discharge (an average of ≤ 12.3 days post-index procedure)

Title

Number of Participants With Procedural Success

Description

Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA at 30 days.

Time Frame

30 days

Title

Number of Participants With Clinical Durability

Description

Time Frame

12 months

Title

Number of Participants With Clip Implant Rate

Description

Defined as the procedural rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.

Time Frame

On the day of index procedure (≤1 day)

Title

Procedure Time

Description

The mean procedure time is defined as the start time of the transseptal procedure to the time the steerable guide catheter (SGC) is removed.

Time Frame

On the day of index procedure

Title

Device Time

Description

Device time is 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

On the day of index procedure

Title

Fluoroscopy Duration

Description

Mean fluoroscopy duration during the MitraClip procedure.

Time Frame

On the day of index procedure

Title

Number of Participants With MitraClip Devices Implanted

Description

The distribution of number of MitraClip devices implanted in patients.

Time Frame

On the day of index procedure

Title

Post-Procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU)/ Post-anesthesia Care Unit (PACU) Duration

Description

Defined as the number of hours for which patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.

Time Frame

At discharge (an average of ≤ 12.3 days post-index procedure).

Title

Post-Procedure Length of Hospital Stay

Description

Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility.

Time Frame

At discharge (an average of ≤ 12.3 days post-index procedure).

Title

Number of Participants Experiencing Death

Description

Time Frame

12 months visit window (410 days)

Title

Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility

Time Frame

At discharge (an average of ≤ 12.3 days post-index procedure)

Title

Number of Participants With Hospital Re-admissions

Description

Defined as re-admission of patients to the hospital following discharge from the Clip procedure.

Time Frame

30 days

Title

Number of Participants With Device Embolization or Single Leaflet Device Attachment (SLDA)

Description

A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.

Time Frame

0 to 5 years

Title

Number of Participants With Mitral Stenosis

Description

Time Frame

0 to 5 years

Title

Number of Participants With Mitral Regurgitation (MR) Severity

Description

Time Frame

30 days(Follow-up)

Title

Number of Participants With MR Severity

Description

Time Frame

12 months

Title

Number of Participants With MR Severity

Description

Time Frame

2 years

Title

Number of Participants With MR Severity

Description

Time Frame

3 years

Title

Number of Participants With MR Severity

Description

Time Frame

4 years

Title

Number of Participants With MR Severity

Description

Time Frame

5 years

Title

Number of Participants With Second Intervention to Place an Additional Mitraclip Device.

Description

Time Frame

139 days post the index procedure

Title

Number of Participants With Second Intervention to Place an Additional Mitraclip Device.

Description

Time Frame

5 years

Title

Number of Participants With New York Heart Association (NYHA) Functional Class

Description

Time Frame

30 days

Title

Number of Participants With NYHA Functional Class

Description

Time Frame

12 months

Title

Number of Participants With NYHA Functional Class

Description

Time Frame

2 years

Title

Number of Participants With NYHA Functional Class

Description

Time Frame

3 years

Title

Number of Participants With NYHA Functional Class

Description

Time Frame

4 years

Title

Number of Participants With NYHA Functional Class

Description

Time Frame

5 years

Title

Left Ventricular End-diastolic Volume (LVEDV)

Description

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to discharge or 30 days as determined by echo core laboratory.

Time Frame

At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days

Title

Left Ventricular End-diastolic Volume (LVEDV)

Description

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 12 months as determined by echo core laboratory.

Time Frame

12 months

Title

Left Ventricular End-diastolic Volume (LVEDV)

Description

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 24 months as determined by echo core laboratory.

Time Frame

24 months

Title

Left Ventricular End-diastolic Volume (LVEDV)

Description

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 36 months as determined by echo core laboratory.

Time Frame

36 months

Title

Left Ventricular End-diastolic Volume (LVEDV)

Description

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 48 months as determined by the echo core laboratory.

Time Frame

48 months

Title

Left Ventricular End-diastolic Volume (LVEDV)

Description

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 60 months as determined by echo core laboratory.

Time Frame

60 months

Title

Left Ventricular End-systolic Volume (LVESV)

Description

Paired Left ventricular end-systolic volume (LVESV) data from baseline to discharge or 30 days as determined by echo core laboratory.

Time Frame

At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days

Title

Left Ventricular End-systolic Volume (LVESV)

Description

Paired Left ventricular end-systolic volume (LVESV) data from baseline to 12 months as determined by echo core laboratory.

Time Frame

12 months

Title

Left Ventricular End-systolic Volume (LVESV)

Description

Paired Left ventricular end-systolic volume (LVESV) data from baseline to 24 months as determined by echo core laboratory.

Time Frame

24 months

Title

Left Ventricular End-systolic Volume (LVESV)

Description

Paired Left ventricular end-systolic volume (LVESV) data from baseline to 36 months as determined by echo core laboratory.

Time Frame

36 months

Title

Left Ventricular End-systolic Volume (LVESV)

Description

Paired Left ventricular end-systolic volume (LVESV) data from baseline to 48 months as determined by echo core laboratory.

Time Frame

48 months

Title

Left Ventricular End-systolic Volume (LVESV)

Description

Paired Left ventricular end-systolic volume (LVESV) data from baseline to 60 months as determined by echo core laboratory.

Time Frame

60 months

Title

Left Ventricular Internal Dimension Diastole (LVIDd)

Description

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to discharge or 30 days as determined by echo core laboratory.

Time Frame

At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days

Title

Left Ventricular Internal Dimension Diastole (LVIDd)

Description

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 12 months as determined by echo core laboratory.

Time Frame

12 months

Title

Left Ventricular Internal Dimension Diastole (LVIDd)

Description

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 24 months as determined by echo core laboratory.

Time Frame

24 months

Title

Left Ventricular Internal Dimension Diastole (LVIDd)

Description

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 36 months as determined by echo core laboratory.

Time Frame

36 months

Title

Left Ventricular Internal Dimension Diastole (LVIDd)

Description

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 48 months as determined by echo core laboratory.

Time Frame

48 months

Title

Left Ventricular Internal Dimension Diastole (LVIDd)

Description

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 60 months as determined by echo core laboratory.

Time Frame

60 months

Title

Left Ventricular Internal Dimension Systole (LVIDs)

Description

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to discharge or 30 days as determined by echo core laboratory.

Time Frame

At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days

Title

Left Ventricular Internal Dimension Systole (LVIDs)

Description

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 12 months as determined by echo core laboratory.

Time Frame

12 months

Title

Left Ventricular Internal Dimension Systole (LVIDs)

Description

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 24 months as determined by echo core laboratory.

Time Frame

24 months

Title

Left Ventricular Internal Dimension Systole (LVIDs)

Description

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 36 months as determined by echo core laboratory.

Time Frame

36 months

Title

Left Ventricular Internal Dimension Systole (LVIDs)

Description

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 48 months as determined by echo core laboratory.

Time Frame

48 months

Title

Left Ventricular Internal Dimension Systole (LVIDs)

Description

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 60 months as determined by echo core laboratory.

Time Frame

60 months

Title

Left Ventricular Ejection Fraction (LVEF)

Description

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to discharge or 30 days as determined by echo core laboratory.

Time Frame

At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days

Title

Left Ventricular Ejection Fraction (LVEF)

Description

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 12 months as determined by echo core laboratory.

Time Frame

12 months

Title

Left Ventricular Ejection Fraction (LVEF)

Description

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 24 months as determined by echo core laboratory.

Time Frame

24 months

Title

Left Ventricular Ejection Fraction (LVEF)

Description

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 36 months as determined by echo core laboratory.

Time Frame

36 months

Title

Left Ventricular Ejection Fraction (LVEF)

Description

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 48 months as determined by echo core laboratory.

Time Frame

48 months

Title

Left Ventricular Ejection Fraction (LVEF)

Description

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 60 months as determined by echo core laboratory.

Time Frame

60 months

Title

Septal-Lateral Annular Dimension Diastole (SLADd)

Description

Time Frame

At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days

Title

Septal-Lateral Annular Dimension Diastole (SLADd)

Description

Time Frame

12 months

Title

Septal-Lateral Annular Dimension Diastole (SLADd)

Description

Time Frame

24 months

Title

Septal-Lateral Annular Dimension Diastole (SLADd)

Description

Time Frame

36 months

Title

Septal-Lateral Annular Dimension Diastole (SLADd)

Description

Time Frame

48 months

Title

Septal-Lateral Annular Dimension Diastole (SLADd)

Description

Time Frame

60 months

Title

Septal-Lateral Annular Dimension Systole (SLADs)

Description

Time Frame

At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days

Title

Septal-Lateral Annular Dimension Systole (SLADs)

Description

Time Frame

12 months

Title

Septal-Lateral Annular Dimension Systole (SLADs)

Description

Time Frame

24 months

Title

Septal-Lateral Annular Dimension Systole (SLADs)

Description

Time Frame

36 months

Title

Septal-Lateral Annular Dimension Systole (SLADs)

Description

Time Frame

48 months

Title

Septal-Lateral Annular Dimension Systole (SLADs)

Description

Time Frame

60 months

Other Pre-specified Outcome Measures:

Title

36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 30 Days

Description

The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) 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

36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 12 Months

Description

Time Frame

12 months

Title

Change in 6-Minute Walk Test (6MWT)

Description

Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes.

Time Frame

At Baseline and 30 Days

Title

Change in 6-Minute Walk Test (6MWT)

Description

Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes.

Time Frame

At Baseline and 6 months

Title

Change in 6-Minute Walk Test (6MWT)

Description

Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes.

Time Frame

At Baseline and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Patients screened in EVEREST II REALISM Study will first be screened for high risk (HR) status and enrolled into the HR arm if they meet eligibility for this arm of the study. If they do not meet eligibility for the HR arm, patients will be further screened for eligibility for enrollment into the non-high risk (NHR) arm. Key Inclusion Criteria: The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the mitral valve (MV) Male or non-pregnant female Trans-septal catheterization is determined to be feasible by the treating physician High Risk Arm: Predicted procedural mortality risk calculated using the STS surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a HR surgical candidate due to the presence of one of the following indications: Porcelain aorta or mobile ascending aortic atheroma Post-radiation mediastinum Previous mediastinitis Functional MR with EF <40 Over 75 years old with EF<40 Re-operation with patent grafts Two or more prior chest surgeries Hepatic cirrhosis Three or more of the following STS high risk factors 9.1 Creatinine >2.5 mg/dL 9.2 Prior chest surgery 9.3 Age over 75 9.4 EF<35 Symptomatic moderate to severe (3+) or severe (4+) chronic MR and in the judgment of the investigator intervention to reduce MR is likely to provide symptomatic relief for the patient American Society of Anesthesiologists (ASA) physical status classification of ASA IV or lower Non-High Risk Arm: Moderate to severe (3+) or severe (4+) chronic MV regurgitation and: 1. Symptomatic with >25% LVEF and LVESD ≤55mm or, 2. Asymptomatic with one or more of the following: i. Left Ventricular Ejection Fraction (LVEF) 25% to 60% ii. Left Ventricular End-Systolic Diameter (LVESD) ≥40 mm iii. New onset of Atrial fibrillation (AFib) iv. Pulmonary arterial systolic pressure (PASP) >50 mmHg at rest or >60 mmHg with exercise Candidate for MV repair or replacement surgery, including cardiopulmonary bypass Key Exclusion Criteria: Evidence of an Acute Myocardial Infarction (AMI) in the prior 12 weeks of the intended treatment In the judgment of the Investigator, the femoral vein cannot accommodate a 24 French scale (F) catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral Deep Venous Thrombus (DVT) is present MV orifice area <4.0 cm2 If leaflet flail is present: Flail Width ≥15 mm, or Flail Gap ≥10 mm. If leaflet tethering is present: 1. Vertical coaptation length <2 mm Leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in MR. This may include: Evidence of calcification in the grasping area of the A2 and/or P2 scallops Presence of a significant cleft of A2 or P2 scallops More than one anatomic criteria dimensionally near the exclusion limits Bileaflet flail or severe bileaflet prolapse Lack of both primary and secondary chordal support Hemodynamic instability (systolic pressure <90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump). Need for emergency surgery for any reason Prior MV surgery or valvuloplasty or any currently implanted mechanical prosthetic valve or currently implanted Ventricular assist device (VAD) Echocardiographic evidence of intracardiac mass, thrombus or vegetation Active endocarditis or active rheumatic heart disease or leaflets degenerated from either endocarditis or rheumatic disease (i.e. noncompliant, perforated) History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions Life expectancy <12 months Active infections requiring current antibiotic therapy Patients in whom transesophageal echocardiography (TEE) is contraindicated High Risk Arm: EF <20%, and/or LVESD >60 mm Non-High Risk Arm: The need for any other cardiac surgery Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure Severe Left Ventricular (LV) dysfunction (EF <25% and/or LVESD >55mm) Severe mitral annular calcification Systolic anterior motion of the MV leaflet Hypertrophic cardiomyopathy History of a stroke or documented Transient Ischemic Attack (TIA) within the prior 6 months Upper GI bleeding within the prior 6 months Platelet count <75,000 cells/mm³ Creatinine >2.5mg/dL

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ted Feldman, M.D. Feldman, M.D.

Organizational Affiliation

NorthShore University HealthSystem

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Donald D Glower Jr., MD

Organizational Affiliation

Duke University

Official's Role

Study Director

Facility Information:

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

El Camino Hospital

City

Mountain View

State/Province

California

ZIP/Postal Code

94040

Country

United States

Facility Name

University of California Davis Medical Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

University of Colorado Health Sciences Center

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Washington Hospital Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

Baptist Hospital of Miami, FL

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Piedmont Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30309

Country

United States

Facility Name

St. Joseph's Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Evanston Hospital

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

The Care Group Medical Center (St. Vincent Hospital)

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46290

Country

United States

Facility Name

Shawnee Mission Medical Center

City

Shawnee Mission

State/Province

Kansas

ZIP/Postal Code

66204

Country

United States

Facility Name

Terrebonne General Medical Center

City

Houma

State/Province

Louisiana

ZIP/Postal Code

70360

Country

United States

Facility Name

Maine Medical Center

City

Portland

State/Province

Maine

ZIP/Postal Code

04102

Country

United States

Facility Name

William Beaumont Hospital

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

Facility Name

Minneapolis Heart Institute

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55407

Country

United States

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

St. Patrick's Hospital & Health Science Center

City

Missoula

State/Province

Montana

ZIP/Postal Code

59802

Country

United States

Facility Name

Morristown Memorial Hospital

City

Morristown

State/Province

New Jersey

ZIP/Postal Code

07960

Country

United States

Facility Name

New York University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

New York Presbyterian Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Lenox Hill Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10075

Country

United States

Facility Name

St. Francis Hospital

City

Roslyn

State/Province

New York

ZIP/Postal Code

11576

Country

United States

Facility Name

Carolina's Medical Center (Sanger Clinic)

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28203

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

East Carolina Heart Institute

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Oklahoma Heart Hospital

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73120

Country

United States

Facility Name

Hospital of the University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Baylor University Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75226

Country

United States

Facility Name

Memorial Hermann Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77024

Country

United States

Facility Name

University of Texas Health Science Center

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Intermountain Medical Center

City

Murray

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

University of Virginia Health System

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

Facility Name

Swedish Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

Facility Name

St. Luke's Medical Center

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53215

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21741608

Citation

Grayburn PA, Roberts BJ, Aston S, Anwar A, Hebeler RF Jr, Brown DL, Mack MJ. Mechanism and severity of mitral regurgitation by transesophageal echocardiography in patients referred for percutaneous valve repair. Am J Cardiol. 2011 Sep 15;108(6):882-7. doi: 10.1016/j.amjcard.2011.05.013. Epub 2011 Jul 7.

Results Reference

result

PubMed Identifier

23608290

Citation

Pope NH, Lim S, Ailawadi G. Late calcific mitral stenosis after MitraClip procedure in a dialysis-dependent patient. Ann Thorac Surg. 2013 May;95(5):e113-4. doi: 10.1016/j.athoracsur.2012.10.067.

Results Reference

result

PubMed Identifier

25011722

Citation

Glower DD, Kar S, Trento A, Lim DS, Bajwa T, Quesada R, Whitlow PL, Rinaldi MJ, Grayburn P, Mack MJ, Mauri L, McCarthy PM, Feldman T. Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: results of the EVEREST II study. J Am Coll Cardiol. 2014 Jul 15;64(2):172-81. doi: 10.1016/j.jacc.2013.12.062.

Results Reference

result

PubMed Identifier

30586701

Citation

Ailawadi G, Lim DS, Mack MJ, Trento A, Kar S, Grayburn PA, Glower DD, Wang A, Foster E, Qasim A, Weissman NJ, Ellis J, Crosson L, Fan F, Kron IL, Pearson PJ, Feldman T; EVEREST II Investigators. One-Year Outcomes After MitraClip for Functional Mitral Regurgitation. Circulation. 2019 Jan 2;139(1):37-47. doi: 10.1161/CIRCULATIONAHA.117.031733.

Results Reference

derived

PubMed Identifier

25593120

Citation

Wang A, Sangli C, Lim S, Ailawadi G, Kar S, Herrmann HC, Grayburn P, Foster E, Weissman NJ, Glower D, Feldman T. Evaluation of renal function before and after percutaneous mitral valve repair. Circ Cardiovasc Interv. 2015 Jan;8(1):e001349. doi: 10.1161/CIRCINTERVENTIONS.113.001349.

Results Reference

derived

PubMed Identifier

24184254

Citation

Lim DS, Reynolds MR, Feldman T, Kar S, Herrmann HC, Wang A, Whitlow PL, Gray WA, Grayburn P, Mack MJ, Glower DD. Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation after transcatheter mitral valve repair. J Am Coll Cardiol. 2014 Jul 15;64(2):182-92. doi: 10.1016/j.jacc.2013.10.021. Epub 2013 Oct 31.

Results Reference

derived

Links:

URL

https://www.vascular.abbott/us/homepage.html

Description

Web site listing study sites and describing mitral regurgitation, symptoms, clinical consequences and treatments

URL

http://www.abbottvascular.com/us/index.html

Description

Sponsor information

Learn more about this trial

Real World Expanded Multicenter Study of the MitraClip® System (REALISM)

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Real World Expanded Multicenter Study of the MitraClip® System (REALISM) (REALISM)

Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial