New heart valve repair device shows promise in leaky valve patients

NCT ID NCT03170349

First seen Nov 01, 2025 · Last updated May 13, 2026 · Updated 32 times

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 vein, avoiding open-heart surgery. It included 124 adults with moderate-to-severe mitral regurgitation and heart failure. The main goals were to see if the device is safe and effectively reduces the valve leak, with follow-up over one year.

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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

Conditions

Explore the condition pages connected to this study.