Status:
COMPLETED
Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
Conditions:
Mitral Valve Insufficiency
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 be...
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 hear...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT00807040
Start Date
December 1 2008
End Date
March 1 2014
Last Update
March 15 2019
Active Locations (21)
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1
University of Southern California
Los Angeles, California, United States, 90033
2
Emory University
Atlanta, Georgia, United States, 30383
3
Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
4
University of Maryland
Baltimore, Maryland, United States, 21201