Replacement of the Native Mitral Valve Using the ReValve System

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

This study is to collect preliminary chronic information on performance and safety of the ReValve System.

Key Inclusion Criteria:

• Symptomatic functional and/or degenerative MR (≥2+) due to ischemic and non-ischemic cardiomyopathy etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 60 days and transesophageal echocardiogram (TEE) obtained within 90 days prior 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 subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac CT.
• Age greater than 18 years.
• Left Ventricular End Systolic Dimension (LVESD) is ≤ 65 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject consent.

Key Exclusion Criteria:

• Untreated clinically significant coronary artery disease requiring revascularization.
• Need for emergent or urgent surgery for any reason or any planned cardiac surgery within 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 LA thrombus, vegetation or mass
• Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution, anticoagulation therapy) or hypersensitivity to nickel or titanium.