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