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Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System — TIARA-I  

Mitral Valve Regurgitation Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02276547
Study type Interventional
Source Neovasc Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date December 2014
Completion date February 2025
View Details
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