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

Completed · Phase 2

Conditions studied: Mitral Valve Insufficiency, Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT00807040

Run by

Icahn School of Medicine at Mount Sinai

People needed

251

Starts

2008-12-01

Expected to finish

2014-03-01

Last updated by the study team

2019-03-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Southern California — Los Angeles, California, United States
• Emory University — Atlanta, Georgia, United States
• Wellstar Kennestone Hospital — Marietta, Georgia, United States
• University of Maryland — Baltimore, Maryland, United States
• NIH Heart Center at Suburban Hospital — Bethesda, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Montefiore Einstein Heart Center — The Bronx, New York, United States
• Mission Hospital — Asheville, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• East Carolina Heart Institute — Greenville, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Baylor Research Institute — Plano, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Inova Heart and Vascular Institute — Falls Church, Virginia, United States
• Montreal Heart Institute — Montreal, Quebec, Canada
• Hôpital du Sacré-Coeur de Montréal — Montreal, Quebec, Canada
• Quebec Heart Institute/Laval Hopital — Québec, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.