Tiara™ Transcatheter Mitral Valve Replacement Study

Inclusion Criteria: * Severe mitral regurgitation * High surgical risk for open mitral valve surgery * Subject meets anatomical eligibility criteria Exclusion Criteria: * Deemed too frail by objective frailty assessments * Previous cardiac procedures: any mitral valve replacement surgery and cardiac transplant * Unsuitable cardiac structure * Clinically significant untreated Coronary Artery Disease (CAD) * Subjects on chronic dialysis * Pregnant or planning pregnancy within next 12 months * Documented bleeding or coagulation disorders * Active infections requiring antibiotic therapy * Subjects with a life expectancy less than 12 months