CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study

Inclusion Criteria: * NYHA ≥ II * Moderate/severe or severe mitral regurgitation * Prohibitive risk for open-heart surgery * Meets anatomical criteria Exclusion Criteria: * Unsuitable anatomy * Need for emergent or urgent surgery * Prior mechanical aortic valve replacement * Any prior surgical or transcatheter repair (excluding balloon valvuloplasty) or replacement of the mitral valve * Preexisting device in the left ventricular apex * Clinically significant, untreated coronary artery disease * Limited life expectancy (\< 12 months) * Active infection