Heart device aims to cut stroke risk in PFO patients
NCT ID NCT03309332
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at a device called the AMPLATZER PFO Occluder, which is implanted to close a hole in the heart (PFO) in people who have had a stroke. Over 1,200 participants are being followed for up to 5 years to see if the device prevents another stroke and is safe. The goal is to confirm the device works well in real-world use.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
AMPLATZER™ PFO Occluder (a device implanted to close a hole in the heart)
What this could lead to
If successful, this could confirm that the device effectively reduces the risk of another stroke in people with a PFO.
What could go wrong
This is a post-approval study, so the device is already approved. However, it may not work for everyone, and there are risks like device-related complications or serious adverse events.
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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Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania, 15212, United States
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Ascension Texas Cardiovascular Research
Austin, Texas, 78705, United States
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Augusta University
Augusta, Georgia, 30912, United States
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Aurora Medical Group
Milwaukee, Wisconsin, 53215, United States
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Baptist Hospital East
Louisville, Kentucky, 40515, United States
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Baptist Medical Center
Jacksonville, Florida, 32207, United States
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Baylor Scott & White - The Heart Hospital Baylor Plano
Plano, Texas, 75093, United States
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Centro Cardiologico Monzino
Milan, Lombard, Italy
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Chandler Regional Medical Center
Chandler, Arizona, 85224, United States
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Charlton Memorial Hospital
Fall River, Massachusetts, 02720, United States
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Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
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Cleveland Clinic Florida
Weston, Florida, 33331, United States
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Denver Heart
Denver, Colorado, 80031, United States
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Deutsches Herzzentrum Berlin
Berlin, State of Berlin, 13353, Germany
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Erlanger Medical Center
Chattanooga, Tennessee, 37922, United States
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First Coast Cardiovascular Institute
Jacksonville, Florida, 32256, United States
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Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
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Forsyth Medical Center
Winston-Salem, North Carolina, 27358, United States
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Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
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HCA Houston Healthcare Medical Center
Houston, Texas, 77004, United States
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HCA Midwest Division, Menorah Medical Center
Overland Park, Kansas, 66209, United States
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Heart Center Research, LLC
Huntsville, Alabama, 35801, United States
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Henry Ford Hospital
Detroit, Michigan, 48084, United States
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Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, H1T 1C8, Canada
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Jewish Hospital
Cincinnati, Ohio, 45236, United States
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Johns Hopkins University Hospital
Baltimore, Maryland, 21287, United States
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Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
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Kaiser Sunnyside Medical Center
Clackamas, Oregon, 97015, United States
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Kantonsspital St.Gallen
Sankt Gallen, Stgalln, 9007, Switzerland
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Lexington Medical Center
West Columbia, South Carolina, 29169, United States
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Los Robles Hospital and Medical Center
Thousand Oaks, California, 91360, United States
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McLaren Health Care Corporation
Auburn Hills, Michigan, 48326, United States
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MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
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Memorial Hospital of Colorado Springs
Colorado Springs, Colorado, 80909, United States
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Mercy Hospital South
St Louis, Missouri, 63128, United States
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Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
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Moses H Cone Memorial Hospital
Greensboro, North Carolina, 27358, United States
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Mount Sinai Hospital
New York, New York, 10019, United States
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Mt Carmel East
Columbus, Ohio, 43213, United States
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New York Presbyterian Hospital/ Cornell University
New York, New York, 10021, United States
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Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
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Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
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Novant Health Heart and Vascular Research
Charlotte, North Carolina, 28204, United States
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Ochsner Medical Center
New Orleans, Louisiana, 70448, United States
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Ohio Health Research Institute
Columbus, Ohio, 43210, United States
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Ohio State University
Columbus, Ohio, 43210, United States
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Orlando Health
Orlando, Florida, 32806, United States
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Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
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Pima Heart Physicians, PC
Tucson, Arizona, 85712, United States
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Prairie Education and Research Cooperative
Springfield, Illinois, 63146, United States
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Providence Heart and Vascular Institute
Portland, Oregon, 97225, United States
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Providence St. Patrick Hospital
Missoula, Montana, 59802, United States
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Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
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Rush University Medical Center
Chicago, Illinois, 60612, United States
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San Diego Cardiac Center
San Diego, California, 92123, United States
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Sanford USD Medical Center
Sioux Falls, South Dakota, 57117, United States
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Santa Maria Hospital
Lisbon, Lisbon District, 1649-035, Portugal
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Scottsdale Healthcare Shea
Scottsdale, Arizona, 85260, United States
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Sentara Norfolk General Hospital
Norfolk, Virginia, 23112, United States
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South Denver Cardiology Associates PC
Littleton, Colorado, 80120, United States
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Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
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St. Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
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St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
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St. Mary's Hospital
Duluth, Minnesota, 55805, United States
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St. Thomas Hospital
London, London, SE1 7EH, United Kingdom
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St. Vincent's Medical Center
Jacksonville, Florida, 32204, United States
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Stanford University Medical Center
Stanford, California, 94305, United States
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Stony Brook University Medical Center
Stony Brook, New York, 11790, United States
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Sutter Medical Center
Sacramento, California, 95816, United States
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Swedish Medical Center - Heart & Vascular
Seattle, Washington, 98122, United States
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TUM Klinikum - Deutsches Herzzentrum München
München, Bavaria, 80636, Germany
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Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, 37920, United States
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Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
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TriHealth Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
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Tufts Medical Center
Boston, Massachusetts, 02111, United States
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UAMS Medical Center
Little Rock, Arkansas, 72205, United States
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USC University Hospital
Los Angeles, California, 90033, United States
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University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
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University of California at San Francisco
San Francisco, California, 94143, United States
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University of Colorado Hospital
Aurora, Colorado, 80045, United States
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University of Kentucky
Lexington, Kentucky, 40536, 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, 77074, United States
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University of Washington Medical Center
Seattle, Washington, 98195, United States
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University of Wisconsin Hospital
Madison, Wisconsin, 53792, United States
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Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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WellStar Kennestone Hospital
Marietta, Georgia, 98502, United States