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New Catheter-Based valve replacement could offer hope for leaky heart valve patients

NCT ID NCT04221490

Disease control Sponsor: Edwards Lifesciences 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new device called the Edwards EVOQUE system, which replaces the tricuspid valve using a thin tube (catheter) instead of open-heart surgery. The trial includes 228 people with moderate or severe tricuspid regurgitation who still have symptoms despite medical therapy. The goal is to see if the device is safe and can reduce the leak, improve symptoms, and avoid major complications.

What this could mean

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

Active substance
Edwards EVOQUE tricuspid valve replacement system (a device implanted through a catheter to replace the tricuspid valve)
What this could lead to
If successful, this could offer a less invasive treatment option for people with severe tricuspid regurgitation who are not candidates for open-heart surgery.
What could go wrong
This is an early-stage study with only 228 participants, so results may not apply to everyone. Risks include major adverse events like stroke, bleeding, or need for re-intervention.

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

228 people

The number who actually took part.

Started

May 2020

Expected to finish

Jan 2029

An estimate. End dates often move.

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.

Key Inclusion Criteria: * Functional or degenerative TR moderate or greater * Symptomatic despite medical therapy or prior HF hospitalization from TR * The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement Key Exclusion Criteria: * Tricuspid valve anatomic contraindications * Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months * Hemodynamic instability * Refractory heart failure requiring advanced intervention * Currently participating in another investigational study in which the patient has not reached a primary endpoint

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder gastroesophageal reflux disease heart valve disorder tricuspid valve insufficiency

As listed by the trial registrant

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

Cardiovascular diseases Heart valve diseases Tricuspid valve regurgitation

Contacts and locations

Locations

  • Baylor Heart Hopsital Plano

    Plano, Texas, 75093, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CHU Bordeaux, Hôpital Cardiologique Haut Lévêque

    Pessac, 33600, France

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Clinique Pasteur

    Toulouse, 31076, France

  • Columbia University Irving Medical Center / NYPH

    New York, New York, 10032, United States

  • Emory University

    Atlanta, Georgia, 30308, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • InselSpital University Hospital Bern

    Bern, 3010, Switzerland

  • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval (IUCPQ-ULaval)

    Québec, G1V 4G5, Canada

  • Massachusetts General Hospital Boston

    Boston, Massachusetts, 02114, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Northwestern University

    Evanston, Illinois, 60208, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309, United States

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • St. Paul's Hospital Vancouver

    Vancouver, British Columbia, V6Z1Y6, Canada

  • Stanford University

    Stanford, California, 94305, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

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