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

NCT ID NCT04483089

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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