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Worldwide registry aims to unlock secrets of tricuspid valve replacement

NCT ID NCT06033274

Knowledge-focused Sponsor: Montefiore Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This global registry will follow 800 patients receiving a new, less-invasive tricuspid valve replacement (TTVR) for leaky heart valves. Researchers aim to track complications like pacemaker needs and how well the valve works over time. The study does not test a new drug but gathers real-world data to guide future care.

What this could mean

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

Active substance
Transcatheter Tricuspid Valve Replacement (a device procedure to replace the tricuspid valve without open-heart surgery)
What this could lead to
If successful, this registry could provide crucial data to improve the safety and effectiveness of a less invasive valve replacement for people with severe tricuspid regurgitation.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may be limited by differences in patient care across centers.

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 800 people

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

Started

Oct 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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 undergoing orthotopic Transcatheter Tricuspid Valve Replacement for clinically significant tricuspid valve disease.

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: * Patients undergoing Transcatheter Tricuspid Valve Replacement * Native Tricuspid Valve disease * Orthotopic Tricuspid Valve Implantation Exclusion Criteria: * Age under 18 years

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Conditions

The condition(s) this trial relates to.

heart valve disorder tricuspid valve insufficiency

As listed by the trial registrant

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

Tricuspid regurgitation

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    31 sites in 8 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Arizona Heart Hospital (Biltmore Cardiology)

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Ascension Via Christi

    RECRUITING

    Wichita, Kansas, 67214, United States

  • Cardiovascular Center (CVC) Frankfurt, Division of Cardiology

    RECRUITING

    Frankfurt am Main, Hesse, 60389, Germany

  • Centre Hospitalier Universitaire de Lille

    RECRUITING

    Lille, Hauts-de-France, 59000, France

  • Centro Cardiologico Monzino IRCCS

    RECRUITING

    Milan, Lombardy, 20138, Italy

  • Chu De Bordeaux - Haut-Lévêque Hospital

    RECRUITING

    Bordeaux, Pessac, 33600, France

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinique Pasteur Toulouse

    RECRUITING

    Toulouse, Haute-Garonne, 31300, France

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Heart Center Cologne, University of Cologne

    RECRUITING

    Cologne, 50924, Germany

  • Heart and Diabetes Centre, North Rhine-Westphalia (NRW), Ruhr-University

    RECRUITING

    Bad Oeynhausen, 32545, Germany

  • HerzZentrum Hirslanden Zürich

    RECRUITING

    Zurich, CH-8008, Switzerland

  • Hospital Center University De Lille (CHU Lille)

    RECRUITING

    Lille, Hauts-de-France, 59000, France

  • Hospital Clínico Universitario de Valladolid

    RECRUITING

    Valladolid, 47003, Spain

  • Medical Clinic and Polyclinic, University Hospital of Munich (LMU Klinikum)

    RECRUITING

    Munich, Bavaria, 80333, Germany

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10461, United States

  • Montréal Heart Institute (MHI)

    RECRUITING

    Montreal, Quebec, H1T 1C8, Canada

  • Oregon Health & Science University

    ENROLLING_BY_INVITATION

    Portland, Oregon, 97239, United States

  • Providence St. Vincent Medical Center

    RECRUITING

    Portland, Oregon, 97225, United States

    Contact Email: •••••@•••••

  • Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada

    RECRUITING

    Québec, Quebec, G1V 4G5, Canada

  • Rigshospitalet, Copenhagen University Hospital

    RECRUITING

    Copenhagen, Capital Region, 2100, Denmark

  • San Raffaele University Hospital

    RECRUITING

    Milan, Lombardy, 20132, Italy

  • St Michael's Hospital, University of Toronto

    RECRUITING

    Toronto, Ontario, M5B 1W8, Canada

  • St. Paul's Hospital

    RECRUITING

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University Heart Center, Schleswig-Holstein University

    RECRUITING

    Lübeck, Schleswig-Holstein, D-23538, Germany

  • University Heart and Vascular Center, Department of Cardiology

    RECRUITING

    Hamburg, 20251, Germany

  • University Hospital Alvaro Cunqueiro (CHUVI)

    RECRUITING

    Vigo, Pontevedra, 36312, Spain

  • University Hospital Basel

    RECRUITING

    Basel, Canton of Basel-City, 4031, Switzerland

  • University of Duisberg-Essen, West German Heart and Vascular Centre

    RECRUITING

    Essen, North Rhine-Westphalia, 45147, Germany

More trials for these conditions

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