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New clip device shows promise for leaky heart valve in Real-World study

NCT ID NCT04483089

Disease control Sponsor: Abbott Medical Devices 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is tracking 511 patients with severe tricuspid regurgitation who are treated with the Abbott TriClip device in real-world settings. The main goal is to see if the device can successfully reduce the valve leak by at least one grade at discharge. Researchers are also monitoring deaths and the need for repeat procedures over one year. The study aims to provide evidence on how well the device works outside of controlled clinical trials.

What this could mean

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

Active substance
TriClip device (a clip implanted via catheter to repair the tricuspid valve)
What this could lead to
If successful, this study could confirm that the TriClip device is a safe and effective option for reducing leakiness of the tricuspid valve, potentially improving symptoms and quality of life for patients with severe tricuspid regurgitation.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. The device is already approved, but long-term benefits and risks are still being evaluated. Some patients may not experience improvement or could have complications from the procedure.

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

511 people

The number who actually took part.

Started

Aug 2020

Expected to finish

Jan 2028

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

All subjects who have symptomatic severe tricuspid regurgitation despite medical therapy and are eligible to receive the TriClip™ per the current approved Indications For Use.

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: 1. Subjects (\>=18 years age) have severe tricuspid regurgitation and are symptomatic despite medical therapy. 2. Subjects eligible to receive the TriClip™ per the current approved Indications for Use. 3. Subject must provide written informed consent prior to study procedure. Exclusion Criteria: 1\. Subjects participating in another clinical study that may impact the follow-up or results of this study.

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Conditions

The condition(s) this trial relates to.

tricuspid valve insufficiency

As listed by the trial registrant

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

Tricuspid valve regurgitation

Contacts and locations

Locations

  • Azienda Ospedaliera Monaldi

    Naples, Italy

  • Centro Hospitalar Vila Nova de Gaia

    Porto, Portugal

  • DRK Kliniken Köpenick

    Berlin, Germany

  • Elisabeth-Krankenhaus Essen GmbH

    Essen, Germany

  • Herz-und Diabetes Zentrum NRW

    Bad Oeynhausen, Germany

  • HerzKlinik Hirslanden - Klinik Hirslanden

    Zurich, Canton of Zurich, 8032, Switzerland

  • Hospital Clínic de Barcelona

    Barcelona, Barcelona, 08036, Spain

  • Hospital de Sant Pau

    Barcelona, Barcelona, 08025, Spain

  • Hospital Álvaro Cunqueiro

    Vigo, Spain

  • Inselspital Bern

    Bern, 3010, Switzerland

  • Katholisches Marienkrankenhaus GmbH

    Hamburg, Germany

  • Leipzig Heart Center

    Leipzig, Saxony, 04289, Germany

  • Maria Cecilia Hospital

    Cotignola, Italy

  • Odense University Hospital

    Odense, Denmark

  • Otto-von-Guericke-Universität Magdeburg

    Magdeburg, Germany

  • Robert-Bosch-Krankenhaus

    Stuttgart, Germany

  • Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG

    Bad Rothenfelde, Germany

  • St. Antonius Ziekenhuis

    Nieuwegein, Netherlands

  • St.-Johannes-Hospital

    Dortmund, Germany

  • UKE Hamburg (Universitatsklinik Eppendorf)

    Hamburg, Germany

  • Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

    Mainz, Rhineland-Palatinate, 55131, Germany

  • University Hospital Bonn

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Universitätsklinik Graz

    Graz, Austria

  • Universitätsklinikum Ulm

    Ulm, Germany

  • Zentralklinik Bad Berka GmbH

    Bad Berka, Germany

More trials for these conditions

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