This is a study to evaluate the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site’s local heart team as not appropriate for mitral valve surgery. Eligible subjects will be randomized in a 1:1 ratio to the MitraClip device (Device group) or to no MitraClip device (Control group). Approximately 610 subjects will be randomized with approximately 305 subjects targeted to receive the study device.
- Symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology
- Subject has had at least one hospitalization for heart failure in the 12 months prior to subject registration and/or a corrected BNP ≥300 pg/ml or corrected NT-proBNP ≥1500 pg/ml
- Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50%
- Untreated clinically significant coronary artery disease requiring revascularization
- Coronary artery bypass grafting (CABG) within prior 30 days
- Percutaneous coronary intervention within prior 30 days
All subjects will be scheduled for a baseline visit then for a “Treatment” visit. At the “Treatment” visit, Device group subjects will undergo the MitraClip procedure and Control group subjects will be seen by a Heart Failure specialist for a physical exam, including vital signs, cardiac health status and evaluation of heart failure medications. Subjects will have required follow-up evaluations at these time points post-“Treatment” visit: 1-week (phone contact), 30 days, 6 months, 12 months, 18 months, 24 months, and annually thereafter through 5 years. Echocardiogram, electrocardiogram, and blood test (about 2 tablespoon of blood) will be required on each visit.