An evaluation of the ReValve System for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
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
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
Single group
ReValve System
DeviceMitral Valve Replacement Device
Technical Success
Technical Success, is defined as the successful delivery of the ReValve Palmetto Valve and reduction in baseline MR.
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