The REValve Clinical Trial an Evaluation Of the ReValve Palmetto Valve for the Replacement of the Native Mitral VaLVE

Key Inclusion Criteria:

* Symptomatic MR (≥3+) 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 magnetic resonance imaging (MRI)).
* 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 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 or titanium.