Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation
Condition: Mitral Valve Insufficiency; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Mitral Valve Insufficiency
Intervention: Mitral Valve Repair with Annuloplasty; Mitral Valve Replacement
Intervention description: 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.; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 251.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ischemic Mitral Regurgitation; Mitral Valve Disease; Severe Mitral Regurgitation

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 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.
    

Eligibility criteria:

        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