New heart device aims to stop strokes in people with a common hole

NCT ID NCT05069558

First seen Nov 01, 2025 · Last updated May 09, 2026 · Updated 25 times

Summary

This study tests a new device (Occlutech Flex II PFO Occluder) to close a small hole in the heart called a PFO, which can cause strokes. About 450 people who have had a stroke from an unknown cause and have a PFO will receive either the new device or a standard one. The goal is to see if the new device works as well at closing the hole and preventing future strokes.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for STROKE are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Contacts and locations

Locations

  • Aarhus University Hospital

    Aarhus, Denmark

  • Amsterdam University Medical Center

    Amsterdam, Netherlands

  • Arizona Cardiovascular Research Center

    Phoenix, Arizona, 85016, United States

  • Asklepios Klinik Altona Hamburg

    Hamburg, Free and Hanseatic City of Hamburg, 22763, Germany

  • Baystate Medical Center

    Springfield, Massachusetts, 01199, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • CHU Grenoble Alpes

    La Tronche, 38700, France

  • CHU Toulouse Rangueil

    Toulouse, 31400, France

  • CardioVasculäre Centrum Frankfurt

    Frankfurt, 60389, Germany

  • Centre Hospitalier de l'Université de Montreal (CHUM)

    Montreal, Quebec, Canada

  • Colorado Heart and Vascular PC / St. Anthony Hospital

    Lakewood, Colorado, 80228, United States

  • Erasmus University Medical Centre

    Rotterdam, Netherlands

  • Essentia Health

    Duluth, Minnesota, 55804, United States

  • HCA Houston Healthcare Medical Center

    Houston, Texas, 77004, United States

  • Heart and Lung Center, Helsinki University Hospital

    Helsinki, Finland

  • Hôpital Privé Jacques Cartier

    Massy, 91300, France

  • Institut de Cardiologie de Montréal

    Montreal, Quebec, Canada

  • Los Robles Medical Center

    Thousand Oaks, California, 91360, United States

  • MaineHealth

    Portland, Maine, 04102, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637, United States

  • Ohio Health Research Institute

    Columbus, Ohio, 43214, United States

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73120, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7, Canada

  • Rigshospitalet Copenhagen

    Copenhagen, 2100, Denmark

  • Royal Victoria Hospital

    Belfast, United Kingdom

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • South Denver Cardiology Associates

    Littleton, Colorado, 80120, United States

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • The Valley Hospital

    Paramus, New Jersey, 07652, United States

  • Toronto General Hospital

    Toronto, Ontario, Canada

  • Tufts New England Medical Center

    Boston, Massachusetts, 02111, United States

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213, United States

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

  • University Heart Center Lübeck

    Lübeck, 23538, Germany

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University Hospitals Sussex

    Brighton, East Sussex, United Kingdom

  • University of Alberta Mazankowski Heart Institute

    Edmonton, Alberta, Canada

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • Universitätsklinik Heidelberg

    Heidelberg, Germany

  • Vancouver General Hospital

    Vancouver, British Columbia, Canada

  • Vanderbilt Medical Center

    Nashville, Tennessee, 37232, United States

Conditions

Explore the condition pages connected to this study.