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

NCT ID NCT02276547

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

27 people

The number who actually took part.

Started

Feb 2015

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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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

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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