MitraClip REPAIR MR Study

Exclusion Criteria

• •1. Subject is currently participating in another clinical investigation
• •2. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
• •3. Subject has ischemic or non-ischemic secondary MR
• •4. Concomitant severe tricuspid valve regurgitation
• •5. Ejection fraction \<30%
• •6. Severe mitral annular calcification
• •7. Acute myocardial infarction in the past 12 weeks
• •8. Need for cardiac surgery to correct pulmonary valve disease, aortic valve disease, or tricuspid valve disease
• •9. Subjects who have concurrent coronary artery disease that needs to be treated may be included provided the subjects are eligible for both percutaneous coronary intervention (PCI) and coronary artery bypass surgery. Subjects randomized to the device group, must undergo PCI before the MitraClip™ device procedure. Subjects randomized to the surgical (control) arm may undergo coronary artery revascularization during mitral valve repair surgery
• •10. Surgical procedure performed in the past 30 days
• •11. Femoral vein cannot accommodate a 24 F catheter or presence of IVC filter would interfere with the catheter or ipsilateral DVT
• •12. Transesophageal echocardiography (TEE) is contraindicated.
• •13. Hemodynamic instability: systolic pressure ≤ 90 mmHg without afterload reduction, cardiogenic shock, or the need for inotropic support or IABP
• •14. Need for emergency surgery for any reason
• •15. Prior mitral valve surgery, valvuloplasty, mechanical prosthetic valve or VAD
• •16. Systolic anterior motion of the mitral valve
• •17. Hypertrophic cardiomyopathy
• •18. Renal insufficiency requiring dialysis
• •19. Active infections requiring current antibiotic therapy