New heart valve procedure offers hope for High-Risk patients

NCT ID NCT02322840

First seen Nov 25, 2025 · Last updated Apr 30, 2026 · Updated 28 times

Summary

This study tests a new device called the Intrepid Transcatheter Mitral Valve Replacement System for people with severe mitral regurgitation (a leaky heart valve) who are too high-risk for open-heart surgery. The procedure uses a thin tube inserted through a vein in the leg to place the new valve, avoiding major surgery. The goal is to see if the device is safe and works well in 128 participants.

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Contacts and locations

Locations

  • Abbott Northwestern Hospital - EFS

    Minneapolis, Minnesota, 55407, United States

  • Abbott Northwestern Hospital - PILOT

    Minneapolis, Minnesota, 55407, United States

  • Abrazo Arizona Heart Hospital - EFS

    Phoenix, Arizona, 85016, United States

  • Aurora Saint Luke's Medical Center - EFS

    Milwaukee, Wisconsin, 53215, United States

  • Aurora Saint Lukes Medical Center - PILOT

    Milwaukee, Wisconsin, 53215, United States

  • Barnes Jewish Hospital - PILOT

    St Louis, Missouri, 63110, United States

  • Baylor Jack and Jane Hamilton Heart and Vascular Hospital - PILOT

    Dallas, Texas, 75246, United States

  • Cedars-Sinai Medical Center - PILOT

    Los Angeles, California, 90048, United States

  • Centre Hospitalier Régional Universitaire de Lille - PILOT

    Lille, France

  • Clinique Pasteur - PILOT

    Toulouse, France

  • Corewell Health - EFS

    Grand Rapids, Michigan, 49503, United States

  • Guys & St Thomas NHS Foundation Trust - St Thomas Hospital - PILOT

    London, United Kingdom

  • Helsinki University Hospital - PILOT

    Helsinki, FL-00029 HUS, Finland

  • Houston Methodist Hospital - PILOT

    Houston, Texas, 77030, United States

  • Hygeia Hospital - PILOT

    Athens, Greece

  • Monash Health - PILOT

    Clayton, Victoria, 3168, Australia

  • NYU Langone Medical Center - PILOT

    New York, New York, 10016, United States

  • New York-Presbyterian Hospital Columbia University Medical Center - EFS

    New York, New York, 10032, United States

  • New York-Presbyterian Hospital Columbia University Medical Center - PILOT

    New York, New York, 10032, United States

  • Northwestern Memorial Hospital - PILOT

    Chicago, Illinois, 60208, United States

  • Oregon Health & Science University Hospital - EFS

    Portland, Oregon, 97239, United States

  • Piedmont Atlanta Hospital - PILOT

    Atlanta, Georgia, 30309, United States

  • Rigshospitalet - PILOT

    Copenhagen, Denmark

  • Royal Prince Alfred Hospital - PILOT

    Sydney, Australia

  • Royal Sussex County Hospital - PILOT

    Brighton, United Kingdom

  • The Alfred Hospital - PILOT

    Melbourne, Australia

  • The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary - PILOT

    Leeds, LS1 3EX, United Kingdom

  • The Mount Sinai Hospital (New York NY) - EFS

    New York, New York, 10029, United States

  • The Mount Sinai Hospital (New York NY) - PILOT

    New York, New York, 10029, United States

  • UPMC Pinnacle Harrisburg Campus - EFS

    Wormleysburg, Pennsylvania, 17043, United States

  • University of Michigan Health System - University Hospital - PILOT

    Ann Arbor, Michigan, 48109, United States

  • University of Virginia Medical Center - EFS

    Charlottesville, Virginia, 22908, United States

Conditions

Explore the condition pages connected to this study.