RESTOR-MV: Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve

Inclusion Criteria:

• Grade 2, 3, or 4 functional mitral valve regurgitation per 2D echocardiography
• Patient undergoing concomitant coronary artery bypass graft surgery, either on-pump or off-pump
• Left ventricular ejection fraction greater than or equal to 25%
• Age between 18 and 80 years, inclusive
• Patient is willing and available to return for study follow up
• Ability of the patient or legal representative to understand and provide signed consent for participating in the study.

Exclusion Criteria:

• Structural abnormality of the mitral valve (e.g. calcification or thickening of the valve leaflets, ruptured papillary muscle, ruptured chordae tendinae, mitral valve prolapse, mitral stenosis, etc.)
• Asymptomatic Grade 2 MR (those with NYHA Class < II AND LVEF > 40%)
• Organic valve disease resulting in insufficiency or stenosis of the aortic, pulmonary or tricuspid valve requiring surgical intervention
• Transmural myocardial infarction within 30 day period prior to surgical placement of Coapsys
• NYHA class IV
• Left ventricular end diastolic diameter > 7.0 cm
• Cardiac surgery on an emergency or salvage basis
• Left atrial or left ventricular thrombus
• Left ventricular aneurysm
• Previous mitral valve surgery or other previous cardiac surgery that would preclude proper placement of the Coapsys
• Chronic renal failure requiring dialysis
• Open chest surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis, pericarditis)
• Active infection
• Life expectancy of less than 24 months due to conditions other than their cardiac status
• Participation in another investigational drug or device protocol
• Abnormal coronary or cardiac anatomy such that the device could not be placed without interfering with those anatomical structures.