A new heart valve without open surgery? a trial puts it to the test

NCT ID NCT02276547

Completed Disease control Sponsor: Shockwave Medical, Inc. Source: ClinicalTrials.gov ↗

First seen Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This trial tests a new replacement heart valve, the Neovasc Tiara, that is delivered through a small tube (catheter) inserted into the chest. It is designed for people with severe mitral regurgitation—a leaky heart valve—who are too high-risk for traditional open-heart surgery. The study will evaluate how safe the device is and how well it works in the short term.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: a catheter-delivered replacement heart valve called the Neovasc Tiara
What this could lead to: If successful, this could offer a less invasive treatment option for people with severe mitral regurgitation who cannot undergo open-heart surgery.
What could go wrong: This is an early feasibility study with a small number of participants. The procedure carries risks including stroke, bleeding, and need for reintervention, and the valve's long-term durability is unknown.

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease mitral valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MITRAL VALVE REGURGITATION

Contacts and locations

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Locations

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States
Columbia University Medical Center

New York, New York, 10032, United States
Henry Ford Health System

Detroit, Michigan, 48188, United States
London Health Sciences Centre

London, Ontario, N6A 5A5, Canada
Northwestern University

Chicago, Illinois, 60611, United States
St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada
University of Alberta

Edmonton, Alberta, T6G 2B7, Canada
University of Washington Medical Center

Seattle, Washington, 98195, United States
Washington University

St Louis, Missouri, 63110, United States
ZNA Middelheim

Antwerp, B 2060, Belgium

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