New device plugs heart holes without open surgery
NCT ID NCT02985684
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a special device (GORE® CARDIOFORM ASD Occluder) to close a common type of hole in the heart called an atrial septal defect (ASD). The goal was to see if the device could safely and effectively seal the hole using a tube inserted through a blood vessel, avoiding open-heart surgery. 125 people with a hole between 8-35 mm took part. The main results showed that at 6 months, the device successfully closed the hole in most participants, with few serious problems related to the device or procedure.
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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
Locations
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Atrium Health
Charlotte, North Carolina, 28203, United States
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Children's Healthcare at Egleston
Atlanta, Georgia, 30322, United States
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Children's Hospital & Regional Medical Center
Seattle, Washington, 98105, United States
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Children's Hospital Boston
Boston, Massachusetts, 02115, United States
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Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19014, United States
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
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Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
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Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, 10032, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
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Mount Sinai Medical Center
New York, New York, 10029, United States
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Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
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Nicklaus Children's Hospital
Miami, Florida, 33155, United States
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Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
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Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
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Texas Children's Hospital
Houston, Texas, 77030, United States
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The Children's Hospital of Colorado
Aurora, Colorado, 80218, United States
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University of California-Los Angeles
Los Angeles, California, 90095, United States
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University of Michigan
Ann Arbor, Michigan, 48109, United States
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University of Utah
Salt Lake City, Utah, 84113, United States
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Yale University School of Medicine
New Haven, Connecticut, 06520, United States
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Other studies related to the condition(s) this trial covers.
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