Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation

February 28, 2019 updated by: Alan Moskowitz, Icahn School of Medicine at Mount Sinai

Evaluation of Outcomes Following Mitral Valve Repair/Replacement in Severe Chronic Ischemic Mitral Regurgitation

People with coronary artery disease (CAD) or people who have had a heart attack may develop a leak in the mitral valve of their heart and may therefore need to undergo surgery to fix the valve. The best way to fix the mitral valve remains undetermined. This study will evaluate whether it is better for people with severe mitral valve leakage to undergo a mitral valve replacement procedure or a mitral valve repair procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

CAD occurs when the arteries that supply blood to the heart become blocked as a result of plaque buildup. In severe cases, CAD can cause chest pain, shortness of breath, and heart attack. After a heart attack, some people may develop a leak in the mitral valve of the heart. This condition is known as ischemic mitral regurgitation (IMR), and it can cause blood to flow backward into the heart. If left untreated, severe IMR can lead to heart failure or serious heart rhythm irregularities, known as arrhythmias. People with severe mitral valve leakage routinely undergo one of two surgical procedures to fix the mitral valve: a mitral valve repair procedure, in which a surgical ring is used to repair the valve; or a mitral valve replacement procedure, in which the damaged valve is replaced with a new one. Currently, there is no consensus in the medical community as to which procedure is more beneficial. The purpose of this study is to determine whether people with severe mitral valve regurgitation should undergo a mitral valve repair procedure or a mitral valve replacement procedure.

This study will enroll people with CAD who have severe mitral regurgitation. At a baseline study visit, participants will undergo a physical examination; blood collection; neurocognitive tests; and questionnaires regarding medical history, medication history, and quality of life. In the operating room, participants will be randomly assigned to undergo either the mitral valve repair procedure or the mitral valve replacement procedure. Blood, urine, and tissue samples may be collected from participants after the surgery; this is optional and will only be done with prior approval from participants. All participants will attend study visits at Day 30 and Months 6, 12, and 24. At each visit, participants will take part in a medication history review, a physical examination, an echocardiogram, a cardiopulmonary exercise test, neurocognitive tests, and quality of life surveys.

Study Type

Interventional

Enrollment (Actual)

251

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, H7M 3L9
        • Quebec Heart Institute/Laval Hopital
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
      • Montreal, Quebec, Canada, QC H4J 1C5
        • Hôpital du Sacré-Coeur de Montréal
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
    • Georgia
      • Atlanta, Georgia, United States, 30383
        • Emory University
      • Marietta, Georgia, United States, 30060
        • WellStar Kennestone Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
      • Bethesda, Maryland, United States, 20892
        • NIH Heart Center at Suburban Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Einstein Heart Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Hospital
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Greenville, North Carolina, United States, 27834
        • East Carolina Heart Institute
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Texas
      • Plano, Texas, United States, 75093
        • Baylor Research Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Heart and Vascular Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic severe ischemic mitral regurgitation (often with tethering as a major mechanism) in the judgment of the clinical site echocardiographer, assessed by transthoracic echocardiogram. Assessment of mitral regurgitation will be performed using an integrative method (Zoghbi W. et al. J. American Society of Echocardiography. 2003:16:777-802. see appendix). Quantitative guidelines as proposed would be: ERO ≥ 0.4 cmsq. If ERO < 0.4, then the degree of mitral regurgitation will be guided by other color Doppler quantitative methods (jet area/left atrial area ratio, vena contracta, supportive criteria in an integrated fashion
  • Eligible for surgical repair and replacement of mitral valve
  • CAD with or without the need for coronary revascularization

Exclusion Criteria:

  • Any evidence of structural (chordal or leaflet) mitral valve disease or ruptured papillary muscle
  • Prior mitral valve repair
  • Severe irreversible pulmonary hypertension in the judgment of the investigator
  • Medically unable to undergo cardiopulmonary bypass (CPB)
  • Inability to derive ERO and end-systolic volume index (ESVI) by transthoracic echocardiography
  • Planned concomitant intra-operative procedures (with the exception of tricuspid valve repair, closure of patent foramen ovale [PFO] or atrial septal defect [ASD] or Maze procedure)
  • Clinical signs of cardiogenic shock at the time of surgery
  • Treatment with long-term intravenous inotropic therapy at the time of surgery
  • ST segment elevation myocardial infarction (MI) requiring intervention in the 7 days before surgery
  • Congenital heart disease (except PFO or ASD)
  • Evidence of cirrhosis or liver synthetic failure
  • Excessive surgical risk, as judged by the surgical investigator
  • Recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study, as judged by the investigator
  • Therapy with an investigational intervention at the time of screening, or planning to enroll in an additional investigational intervention study during participation in this study
  • Any concurrent disease with a life expectancy of less than 2 years
  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mitral Valve Repair with Annuloplasty
Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
Procedure: Mitral Valve Repair with Annuloplasty
The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed.
Active Comparator: Mitral Valve Replacement
Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.
Procedure: Mitral Valve Replacement
Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)
Time Frame: Measured at Month 12
Measured at Month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause Mortality
Time Frame: Measured at Month 24
Measured at Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Study Chair: Timothy Gardner, MD, Christiana Care Health Services
  • Study Chair: Patrick O'Gara, MD, Brigham and Women's Hospital
  • Principal Investigator: Annetine C. Gelijns, Ph.D., Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

December 10, 2008

First Submitted That Met QC Criteria

December 10, 2008

First Posted (Estimate)

December 11, 2008

Study Record Updates

Last Update Posted (Actual)

March 15, 2019

Last Update Submitted That Met QC Criteria

February 28, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 08-1078-00002
  • U01HL088942 (U.S. NIH Grant/Contract)
  • 595 (Ct Surgery Network Research Group)
  • U01 HL088942-01-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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