Tiara™ Transcatheter Mitral Valve Replacement Study

Tiara™ Transcatheter Mitral Valve Replacement Study (TIARA-II)

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