New heart valve shows promise for High-Risk patients

NCT ID NCT04555967

First seen Apr 25, 2026 · Last updated Apr 30, 2026 · Updated 1 time

Summary

This study looks at the SAPIEN 3 Ultra heart valve in 200 people with severe, symptomatic aortic stenosis who are at intermediate or higher risk for open-heart surgery. The goal is to see if the valve works well and is safe, measuring things like survival, need for repeat procedures, and valve performance. Participants are followed after the procedure to track complications and outcomes.

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Contacts and locations

Locations

  • Aarhus University Hospital, Skejby

    Aarhus, 8200, Denmark

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • Deutsches Herzzentrum Berlin

    Berlin, 13353, Germany

  • Helsinki University Hospital

    Helsinki, 00100, Finland

  • King's College Hospital London

    London, SE5 9RS, United Kingdom

  • Medizinische Universitaet Wien

    Vienna, 1090, Austria

  • Ospedale G. Pasquinucci

    Massa, 54100, Italy

  • Royal Victoria Hospital Belfast

    Belfast, BT12 6BA, United Kingdom

  • St. Paul's Hospital Vancouver

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX, Netherlands

  • Universitares Herzzentrum Hamburg

    Hamburg, 20251, Germany

Conditions

Explore the condition pages connected to this study.