Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System

Early Feasibility Study of the Neovasc Tiara™ Mitral Transcatheter Heart Valve With the Tiara™ Transapical Delivery System

The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.

This is an international, multicenter, single arm, prospective, Early Feasibility Clinical Study to evaluate the safety and performance of the Neovasc Tiara Mitral Valve System in subjects with symptomatic severe mitral regurgitation requiring mitral valve replacement who are at high risk for open chest surgery.

A maximum of 30 subjects will be implanted in this study at a maximum of 10 sites. A maximum of 15 subjects will be implanted in the United States.

Subjects satisfying the inclusion criteria and exclusion criteria will be enrolled to receive the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Delivery System via a transcatheter mitral valve replacement (TMVR) procedure.

Inclusion Criteria:

• Severe symptomatic mitral regurgitation (Stage D)
• High surgical risk for open mitral valve surgery
• Subject meets the anatomical eligibility criteria for available size(s)
• NYHA Class III or IV heart failure

Exclusion Criteria:

• DMR deemed by the heart team to be operable.
• Prohibitive risk, deemed too frail or listed for cardiac transplant.
• Unsuitable cardiac structure