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New device could fix leaky heart valves without Open-Heart surgery

NCT ID NCT04614402

Ongoing Disease control Sponsor: Edwards Lifesciences Source: ClinicalTrials.gov ↗

First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This trial tests a device called the Edwards PASCAL system, which is used to repair a leaky tricuspid valve in the heart without open-heart surgery. The study includes 300 people with severe tricuspid regurgitation who are candidates for this procedure. Researchers are checking how safe and effective the device is by tracking complications and how much the valve leakage improves.

What this could mean

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

Active substance
a device called the Edwards PASCAL Transcatheter Valve Repair System, which is threaded through a blood vessel to repair the tricuspid valve without open-heart surgery
What this could lead to
If successful, this could offer a less invasive treatment option for people with severe tricuspid regurgitation, potentially reducing symptoms and improving quality of life without the need for open-heart surgery.
What could go wrong
This is a post-market study, so the device is already approved, but it may still have risks like bleeding, infection, or the repair not lasting. The results may not apply to all patients with tricuspid regurgitation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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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 INSUFFICIENCY

Contacts and locations

Locations

  • Heart Centre of the University Leipzig

    Leipzig, Saxony, 04289, Germany

  • Herz- und Diabeteszentrum NRW - Bad Oeynhausen

    Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

  • Herzzentrum Universitätsklinikum Köln

    Cologne, DEU, D-50937, Germany

  • Herzzentrum der Universitätsklinik Bonn

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Hygeia Hospital

    Athens, 151 23, Greece

  • Inselspital

    Bern, 3010, Switzerland

  • Kath. Marienkrankenhaus Hamburg gGmbH

    Hamburg, 22087, Germany

  • Medizinische Klinik I- Campus Grosshadern

    München, Bavaria, 81377, Germany

  • Ospedale del Cuore "G. Pasquinucci"

    Massa, Italy

  • UKE Hamburg

    Hamburg, 20246, Germany

  • University Heart Center Lübeck

    Lübeck, Germany

  • Universitätsklinikum Tübingen Innere Medizin III - Kardiologie und Angiologie

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitätsklinikum Ulm Innere Medizin II

    Ulm, Baden-Wurttemberg, 89070, Germany

  • Westdeutsches Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie

    Essen, Nordrhine Westfalia, 45147, Germany

  • Zentralklinik Bad Berka GmbH

    Bad Berka, Thuringia, 99437, Germany

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