Tiara™ Transcatheter Mitral Valve Replacement Study
Tiara™ Transcatheter Mitral Valve Replacement Study
To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve
 with the Tiara Transapical Delivery System.
The TIARA-II study is an international, multicenter, single-arm, prospective, safety and
 performance clinical 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