Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional MR

Inclusion Criteria: * Subjects who have national Medicare coverage by CMS * Symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology * Subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure * 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 * New York Heart Association (NYHA) Functional Class II, III or ambulatory IV * Surgery will not be offered as a treatment option and medical therapy is the intended therapy for the subject * Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50% * Left Ventricular End Systolic Dimension (LVESD) is ≤70 mm Exclusion Criteria: * Untreated clinically significant coronary artery disease requiring revascularization * Coronary artery bypass grafting (CABG) within prior 30 days * Percutaneous coronary intervention within prior 30 days * Tricuspid valve disease requiring surgery * Aortic valve disease requiring surgery * Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use * Cerebrovascular accident within prior 30 days * Severe symptomatic carotid stenosis (\> 70% by ultrasound) * Carotid surgery within prior 30 days * Mitral valve orifice area \< 4.0 cm2 * Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip