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New registry tracks outcomes of keyhole heart valve procedure in 1,000 patients

NCT ID NCT04688190

Knowledge-focused Sponsor: Universitätsklinikum Hamburg-Eppendorf 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This registry is following 1,000 patients with a leaky mitral valve (mitral regurgitation) who undergo a minimally invasive procedure called transcatheter mitral valve replacement (TMVR). The goal is to see how well the procedure works in everyday medical practice, including how it affects heart function and patient survival. Researchers will also compare outcomes with other treatments like surgical repair or medication.

What this could mean

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

Active substance
transcatheter mitral valve replacement (TMVR) procedure
What this could lead to
If successful, this registry could help doctors understand which patients benefit most from TMVR and improve treatment guidelines for mitral regurgitation.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient selection and real-world variability.

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 1,000 people

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

Started

Nov 2020

Expected to finish

Dec 2030

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

This study aimes to include all patients with significant mitral insufficiency, who underwent screening for possible transcatheter mitral valve implantation (TMVI), irrespective of the subsequent therapy.

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: * clinically significant mitral insufficiency * patient underwent screening for TMVI * echocardiography data at baseline (and after TMVI, E2E and surgery) * follow-up of at least 30 days Exclusion Criteria: \- age under 18 years

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

mitral valve disorder mitral valve insufficiency

As listed by the trial registrant

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

Mitral annular calcification Mitral regurgitation Mitral valve disease

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

    43 sites in 13 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

  • ASST Spedali Civili di Brescia

    RECRUITING

    Brescia, Italy

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • CHU Bordeaux

    RECRUITING

    Bourdeaux, France

  • Cedars-Sinai Medical Center, Los Angeles

    RECRUITING

    Los Angeles, California, 90048, United States

  • Civils Hospices of Lyon

    RECRUITING

    Lyon, France

  • Clinique Pasteur

    RECRUITING

    Toulouse, France

  • German Heart Center Berlin

    RECRUITING

    Berlin, Germany

  • German Heart Centre Munich

    RECRUITING

    Munich, Germany

  • Goethe-Universität - University Hospital Frankfurt

    RECRUITING

    Frankfurt, Germany

  • HDZ Bad Oeynhausen

    RECRUITING

    Bad Oeynhausen, Germany

  • Heart Center Bonn

    RECRUITING

    Bonn, Germany

  • Heart Center of the University Medical Center Mainz

    RECRUITING

    Mainz, Germany

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • IRCCS Humanitas Research Hospital

    RECRUITING

    Milan, 20089, Italy

    Contact Email: •••••@•••••

  • IRCCS Policlinico San Donato

    RECRUITING

    Milan, Italy

    Contact Email: •••••@•••••

  • Inselspital Bern

    RECRUITING

    Bern, Switzerland

  • Interbalkan Medical Center

    RECRUITING

    Thessaloniki, Greece

    Contact Email: •••••@•••••

  • LMU Munich

    RECRUITING

    Munich, Germany

  • Lille University Hospital

    RECRUITING

    Lille, France

  • Medical University of Vienna

    RECRUITING

    Vienna, Austria

    Contact Email: •••••@•••••

  • Minneapolis Heart Institute at Abbott Northwestern Hospital

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

    Contact Email: •••••@•••••

  • Montefiore Medical Center

    RECRUITING

    New York, New York, 10461, United States

  • Morristown Medical Center

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Oklahoma Heart Hospital

    RECRUITING

    Oklahoma City, Oklahoma, 73120, United States

  • Poznan University of Medical Sciences

    RECRUITING

    Poznan, Poland

    Contact Email: •••••@•••••

  • Québec Heart and Lung Institute (Laval University)

    RECRUITING

    Québec, Quebec, G1V 4G5, Canada

    Contact Email: •••••@•••••

  • Rigshospitalet

    RECRUITING

    Copenhagen, Denmark

  • Rikshospitalet, Oslo University Hospital (OUS)

    RECRUITING

    Oslo, Norway

  • Royal Brompton Hospital

    RECRUITING

    London, United Kingdom

  • San Raffaele University Hospital

    RECRUITING

    Milan, Italy

  • St Thomas' Hospital - London

    RECRUITING

    London, United Kingdom

  • St Vincent's Hospital

    RECRUITING

    Sydney, Australia

  • St. Paul's Hospital

    RECRUITING

    Vancouver, Canada

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606, United States

    Contact Email: •••••@•••••

  • Toronto Heart Center

    RECRUITING

    Toronto, Canada

  • Tucson Medical Center

    RECRUITING

    Tucson, Arizona, 85712, United States

    Contact Email: •••••@•••••

  • USZ Zurich

    RECRUITING

    Zurich, Switzerland

  • University Heart Center Lübeck

    RECRUITING

    Lübeck, Germany

    Contact Email: •••••@•••••

  • University Heart and Vascular Center Hamburg

    RECRUITING

    Hamburg, Germany

  • University Hospital of Cologne

    RECRUITING

    Cologne, Germany

  • University Hospital of Pisa

    RECRUITING

    Pisa, Italy

  • University Medical Center Ulm

    RECRUITING

    Ulm, Germany

    Contact Email: •••••@•••••

  • Warsaw Medicover Hospital

    RECRUITING

    Warsaw, Poland

    Contact Email: •••••@•••••

More trials for these conditions

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