New heart device aims to prevent strokes in patients with a hole in the heart
NCT ID NCT05069558
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new device called the Occlutech Flex II PFO Occluder, which is used to close a small hole in the heart (PFO) that can cause strokes. The trial involves 450 people who have had a stroke with no clear cause and a PFO. Researchers want to see if the new device works as well as standard devices at closing the hole and preventing future strokes.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
Occlutech Flex II PFO Occluder (a device implanted to close a hole in the heart)
What this could lead to
If successful, this device could offer a safe and effective alternative for closing PFOs, potentially reducing stroke risk in patients with unexplained strokes.
What could go wrong
This is a non-inferiority trial, meaning it aims to show the new device is as good as existing ones, not better. The study is active but not recruiting, and results are pending. Device procedures carry risks like infection or blood clots.
Disclaimer
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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.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Aarhus University Hospital
Aarhus, Denmark
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Amsterdam University Medical Center
Amsterdam, Netherlands
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Arizona Cardiovascular Research Center
Phoenix, Arizona, 85016, United States
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Asklepios Klinik Altona Hamburg
Hamburg, Free and Hanseatic City of Hamburg, 22763, Germany
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Baystate Medical Center
Springfield, Massachusetts, 01199, United States
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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CHU Grenoble Alpes
La Tronche, 38700, France
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CHU Toulouse Rangueil
Toulouse, 31400, France
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CardioVasculäre Centrum Frankfurt
Frankfurt, 60389, Germany
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Centre Hospitalier de l'Université de Montreal (CHUM)
Montreal, Quebec, Canada
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Colorado Heart and Vascular PC / St. Anthony Hospital
Lakewood, Colorado, 80228, United States
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Erasmus University Medical Centre
Rotterdam, Netherlands
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Essentia Health
Duluth, Minnesota, 55804, United States
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HCA Houston Healthcare Medical Center
Houston, Texas, 77004, United States
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Heart and Lung Center, Helsinki University Hospital
Helsinki, Finland
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Hôpital Privé Jacques Cartier
Massy, 91300, France
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Institut de Cardiologie de Montréal
Montreal, Quebec, Canada
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Los Robles Medical Center
Thousand Oaks, California, 91360, United States
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MaineHealth
Portland, Maine, 04102, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
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OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
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Ohio Health Research Institute
Columbus, Ohio, 43214, United States
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Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120, United States
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Oregon Health & Science University
Portland, Oregon, 97239, United States
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Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
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Rigshospitalet Copenhagen
Copenhagen, 2100, Denmark
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Royal Victoria Hospital
Belfast, United Kingdom
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Rush University Medical Center
Chicago, Illinois, 60612, United States
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South Denver Cardiology Associates
Littleton, Colorado, 80120, United States
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Stanford University Medical Center
Stanford, California, 94305, United States
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The Ohio State University
Columbus, Ohio, 43210, United States
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The Valley Hospital
Paramus, New Jersey, 07652, United States
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Toronto General Hospital
Toronto, Ontario, Canada
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Tufts New England Medical Center
Boston, Massachusetts, 02111, United States
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UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
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Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany
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University Heart Center Lübeck
Lübeck, 23538, Germany
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
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University Hospitals Sussex
Brighton, East Sussex, United Kingdom
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University of Alberta Mazankowski Heart Institute
Edmonton, Alberta, Canada
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University of Louisville
Louisville, Kentucky, 40202, United States
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University of Michigan
Ann Arbor, Michigan, 48109, United States
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University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
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University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
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Universitätsklinik Heidelberg
Heidelberg, Germany
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Vancouver General Hospital
Vancouver, British Columbia, Canada
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Vanderbilt Medical Center
Nashville, Tennessee, 37232, United States