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New heart valve fix without cutting chest shows promise for High-Risk patients

NCT ID NCT04029363

Recruiting now Disease control Sponsor: HighLife SAS Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study is testing a new device called the HighLife 28mm mitral valve, which is placed through a tube in a vein to replace a leaky heart valve without open-heart surgery. It is for 120 people with moderate-severe or severe mitral regurgitation who are at high risk for surgery. The goal is to see if the device is safe and works well.

What this could mean

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

Active substance
HighLife Transcatheter Mitral Valve Replacement device
What this could lead to
If successful, this could offer a less invasive treatment option for people with severe mitral regurgitation who are too high-risk for open-heart surgery.
What could go wrong
This is an early study with only 120 participants, so results may not apply to everyone. The procedure carries risks like bleeding, infection, or device complications.

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.

mitral valve insufficiency

As listed by the trial registrant

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

MITRAL REGURGITATION

Contacts and locations

Locations

  • AZ Sint-Jan

    RECRUITING

    Bruges, 8000, Belgium

  • Barts Heart Center

    TERMINATED

    London, United Kingdom

  • Brighton and Sussex University Hospital

    RECRUITING

    Brighton, BN2 5BE, United Kingdom

  • CHRU Strasbourg

    RECRUITING

    Strasbourg, France

  • CHU Bordeaux

    RECRUITING

    Pessac, 33600, France

  • CHU Lille

    RECRUITING

    Lille, France

  • CHU de Rennes

    RECRUITING

    Rennes, 35000, France

  • Centr Cardiologiqque du Nord

    RECRUITING

    Saint-Denis, France

  • Centre Hospitalo-Universitaire de Nantes

    RECRUITING

    Nantes, France

  • Clinque Pasteur

    RECRUITING

    Toulouse, 31076, France

  • Deutsches Herzzentrum Munchen

    RECRUITING

    Munich, Germany

  • European Hospital George Pompidou

    TERMINATED

    Paris, 5015, France

  • Guy's and St. Thomas' NHS Foundation Trust - St. Thomas Hospital

    RECRUITING

    London, SE1 9RS, United Kingdom

  • Heart Center, University Hospital Dresden

    RECRUITING

    Dresden, Germany

  • Herzentrum Leipzig

    RECRUITING

    Leipzig, 04289, Germany

  • Hopital Prive - Jacques Cartier

    RECRUITING

    Massy, France

  • Institute of Cardiology

    RECRUITING

    Warsaw, 04-628, Poland

  • John Hunter Hospital

    RECRUITING

    Newcastle, New South Wales, 2305, Australia

  • John Hunter Hospital

    RECRUITING

    Newcastle, Australia

  • John Radcliffe

    TERMINATED

    Oxford, United Kingdom

  • Leeds Teaching Hospitals NHS Trust

    TERMINATED

    Leeds, United Kingdom

  • Macquarie University Hospital

    WITHDRAWN

    Sydney, New South Wales, 2109, Australia

  • Medical University of Gdansk

    RECRUITING

    Gdansk, Poland

  • Medical University of Silesia Hospital

    RECRUITING

    Katowice, 40-635, Poland

  • Medical University of Warsaw

    RECRUITING

    Warsaw, 02-097, Poland

  • Mediinisches Versorgungszentrum

    RECRUITING

    Hamburg, Germany

  • Medipole Lyon-Villeurbanne

    RECRUITING

    Lyon, France

  • Mount Hospital

    RECRUITING

    Perth, 6150, Australia

  • National Heart Center Singapore

    RECRUITING

    Singapore, Singapore

  • North Shore Private Hospital

    RECRUITING

    Sydney, Australia

  • Princess Alexandra Hospital

    RECRUITING

    Brisbane, Australia

  • Rangueil University Hospital

    RECRUITING

    Toulouse, Toulouse, 31400, France

  • Rangueil University Hospital

    RECRUITING

    Toulouse, France

  • Royal Infirmary of Edinburgh

    RECRUITING

    Edinburgh, United Kingdom

  • Royal Victoria Hospital

    RECRUITING

    Belfast, United Kingdom

  • St. Andrew's Hospital

    RECRUITING

    Adelaide, 5000, Australia

  • St. Vincent's Hospital - Sydney

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

  • The Alfred Hospital

    RECRUITING

    Melbourne, 3004, Australia

  • The Wesley Hospital

    RECRUITING

    Auchenflower, Queensland, 4066, Australia

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Universitaetsklinikum Bonn

    RECRUITING

    Bonn, 53127, Germany

  • Universitatsklink Hamburg-Eppendorf

    RECRUITING

    Hamburg, 20246, Germany

  • University Heart Center Freiburg - Bad Krozingen

    TERMINATED

    Bad Krozingen, 79189, Germany

  • University Hospital Heidelberg

    TERMINATED

    Heidelberg, Germany

  • University Hospital Ulm

    RECRUITING

    Ulm, 89081, Germany

  • University Hospital of Lord's Transfiguration

    TERMINATED

    Poznan, 61-848, Poland

  • University Hospitals of Leicester NHS Trust

    TERMINATED

    Leicester, United Kingdom

  • University Medicine Dept of Cardiology

    TERMINATED

    Rostock, Germany

  • Warringal Hospital

    TERMINATED

    Heidelberg, 3084, Australia

  • ZNA Middelheim

    RECRUITING

    Antwerp, 2020, Belgium

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