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

Prior treatment

• Coronary artery bypass grafting (CABG) within prior 30 days
• Percutaneous coronary intervention within prior 30 days
• Cerebrovascular accident within prior 30 days
• Carotid surgery within prior 30 days

Other illness

• Untreated clinically significant coronary artery disease requiring revascularization
• 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

Other

• Severe symptomatic carotid stenosis (\> 70% by ultrasound)
• 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

• 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