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

ShockWave Medical

Status: Active, not recruiting

Conditions: Mitral Valve Regurgitation

Treatments: Device: Mitral valve replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT02276547

047-CPT-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Treatment

Experimental group

Description:

Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system

Treatment:

Device: Mitral valve replacement