Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a catheter valve fix a leaky heart valve without open surgery?

NCT ID NCT06569602

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This study tests whether the Edwards EVOQUE system, a valve replacement delivered through a catheter, can safely and effectively treat tricuspid regurgitation, a condition where the tricuspid valve fails to close properly. Researchers will enroll 500 adults in Europe who are deemed suitable for this procedure by their heart team. The main goals are to see how many patients achieve a near-normal valve function and to track major complications within 30 days, along with longer-term outcomes like survival and heart failure hospitalizations.

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 transcatheter tricuspid valve replacement system, a device placed through a catheter to replace the tricuspid valve
What this could lead to
If it works, 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 a real-world study without a comparison group, so results may not prove the device is better than other treatments. Risks include major adverse events like bleeding, infection, or device-related complications within 30 days.

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.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Sep 2033

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.

Who is studied

Patients with at least severe tricuspid regurgitation who are candidates for transcatheter tricuspid valve replacement, selected to receive treatment with the EVOQUE system per the current Instructions for use, and meet the eligibility requirements.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1. The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement with the EVOQUE system per the current instructions for use. 2. Patient agrees to attend follow-up assessments. 3. Patients provided written informed consent for participation in the study. Exclusion Criteria: 1. Patient participating in another interventional biologic, drug, or device clinical study that has not met its primary endpoint(s). 2. Any patient considered to be part of a vulnerable population.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cardiovascular diseases are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

cardiovascular disorder 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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asklepios Klinik St Georg Hamburg

    RECRUITING

    Hamburg, Germany

  • Centro Cardiologico Monzino Milano

    RECRUITING

    Milan, Italy

  • Deutsches Herzzentrum Muenchen (DHM)

    RECRUITING

    Munich, Germany

  • Deutsches Herzzentrum der Charité (DHZC)

    RECRUITING

    Berlin, Germany

  • Herz-und Diabeteszentrum NRW

    RECRUITING

    Bad Oeynhausen, Germany

  • Herzzentrum Universitaet Bonn

    RECRUITING

    Bonn, Germany

  • Hospital Clinico San Carlos - Madrid

    RECRUITING

    Madrid, Spain

  • Hygeia Hospital - Athens

    ACTIVE_NOT_RECRUITING

    Athens, Greece

  • Inselspital

    RECRUITING

    Bern, Switzerland

  • Johannes Gutenberg Universitaet Mainz

    RECRUITING

    Mainz, Germany

  • Kerckhoff-Klinik GmbH Bad Nauheim

    RECRUITING

    Bad Nauheim, Germany

  • Klinikum der Universitaet Muenchen - Grosshadern

    RECRUITING

    Munich, Germany

  • Leipzig Herzzentrum

    RECRUITING

    Leipzig, Germany

  • Oxford John Radcliffe Hospital

    RECRUITING

    Oxford, United Kingdom

  • Rhoen-Klinikum Campus - Bad Neustadt

    RECRUITING

    Bad Neustadt an der Saale, Germany

  • St. Johannes Hospital Dortmund

    RECRUITING

    Dortmund, Germany

  • Universitaetsklinikum Schleswig Holstein Campus Kiel

    RECRUITING

    Kiel, Germany

  • Universitaetsklinikum Schleswig Holstein Campus Lubeck

    RECRUITING

    Lübeck, Germany

  • Universitaetsklinikum Tuebingen

    RECRUITING

    Tübingen, Germany

  • Universitaetsklinikum Ulm

    ACTIVE_NOT_RECRUITING

    Ulm, Germany

  • Universitatsklinik Essen

    RECRUITING

    Essen, Germany

  • University Hospital Ramon Y Cajal Madrid

    RECRUITING

    Madrid, Spain

  • Zentralklinik Bad Berka GmbH

    RECRUITING

    Bad Berka, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.