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