A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System

Key Inclusion Criteria:

• Symptomatic MR (≥3+) due to ischemic and non-ischemic cardiomyopathy etiologydetermined by assessment of a qualifying transthoracic echocardiogram (TTE) obtainedwithin 60 days and transesophageal echocardiogram (TEE) obtained within 90 daysprior to subject registration, with MR severity based principally on the TTE study.

• New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.

• Left Ventricular Ejection Fraction (LVEF) is ≥30% (within 90 days prior to subjectregistration, assessed by the site using any one of the following methods:echocardiography, contrast left ventriculography, gated blood pool scan or cardiacmagnetic resonance imaging (MRI)).

• Age greater than 18 years

• Left Ventricular End Systolic Dimension (LVESD) is ≤ 65 mm assessed by site based ona transthoracic echocardiographic (TTE) obtained within 90 days prior to subjectconsent.

Key Exclusion Criteria:

• Untreated clinically significant coronary artery disease requiringrevascularization.

• Need for emergent or urgent surgery for any reason or any planned cardiac surgerywithin the next 12 months.

• Status 1 heart transplant or prior orthotopic heart transplantation

• Cerebrovascular accident within 30 days prior to subject's consent

• Pregnant or planning pregnancy within next 12 months.

• Currently participating in an investigational drug or another device study.

• Evidence of LV or left atrium (LA) thrombus, vegetation or mass

• Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution, anticoagulation therapy) or hypersensitivity to nickel ortitanium.