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New catheter device offers hope for leaky heart valve patients

NCT ID NCT03170349

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

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new device called the Edwards PASCAL system, which repairs leaky mitral heart valves using a thin tube inserted through a blood vessel, avoiding open-heart surgery. It involved 124 adults with moderate-to-severe mitral regurgitation who were candidates for surgery. The goal was to see if the device safely reduces valve leakage and improves symptoms, with follow-up over one year.

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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 VALVE REGURGITATION

Contacts and locations

Locations

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hygeia Hospital

    Athens, 15123, Greece

  • Inselspital, University Hospital Bern

    Bern, 3010, Switzerland

  • Metro North Hospital & Health Service, The Prince Charles Hospital

    Brisbane, Chermside, QLD 4032, Australia

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201, United States

  • San Rafaelle Hospital

    Milan, 20132, Italy

  • St Michael Hospital

    Toronto, Ontario, M5B-1W8, Canada

  • St. Paul's Hospital, Providence Health Care Research Institute

    Vancouver, British Columbia, V6E 1M7, Canada

  • Sunnybrook Hospital

    Toronto, Ontario, M4N 3M5, Canada

  • Sydney Local Health District, Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093, United States

  • Universitaetsklinikum Bonn, Medizinische Klinik II, Kardiologie

    Bonn, 53127, Germany

  • University of Colorado Denver

    Aurora, Colorado, 80045, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

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