Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System

Completed · Not applicable

Conditions studied: Mitral Valve Regurgitation

In brief

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.

Key facts

Study ID

NCT02276547

Run by

Shockwave Medical, Inc.

People needed

27

Starts

2015-02-05

Expected to finish

2024-12-09

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States
• Northwestern University — Chicago, Illinois, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Washington University — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• University of Washington Medical Center — Seattle, Washington, United States
• ZNA Middelheim — Antwerp, Belgium
• University of Alberta — Edmonton, Alberta, Canada
• St. Paul's Hospital — Vancouver, British Columbia, Canada
• London Health Sciences Centre — London, Ontario, Canada

Full record on ClinicalTrials.gov

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