Heart device under watch: 5-Year safety tracking begins
NCT ID NCT07005232
Summary
This study is monitoring the long-term safety and performance of a specific heart defibrillator lead (the OmniaSecure™) after it has been approved for sale. It will follow 2,000 patients who have this device implanted to treat dangerously fast heart rhythms. Researchers will track patients for the lifetime of their device, with a key analysis after 500 patients reach 5 years, to see how well the lead holds up and if any problems occur.
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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Contacts and locations
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Locations
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COR Healthcare
Torrance, California, 90505- 5100, United States
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Childrens Hospital Colorado
Aurora, Colorado, 80045-7106, United States
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Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
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Duke University Medical Center (DUMC)
Durham, North Carolina, 27705-4699, United States
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Geisinger Medical Center
Danville, Pennsylvania, 17822-9800, United States
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Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
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Hartford Hosptial
Hartford, Connecticut, 06106, United States
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Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec, Quebec, G1V4G5, Canada
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Iowa Heart Center (West Des Moines IA)
West Des Moines, Iowa, 50266-8209, United States
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Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
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Metropolitan Cardiology Consultants
Coon Rapids, Minnesota, 55433-4568, United States
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Michigan Heart
Ypsilanti, Michigan, 48197-8633, United States
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Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
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North Memorial Health Heart & Vascular Center
Robbinsdale, Minnesota, 55422-4391, United States
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Northwell Health Huntington Hospital
Huntington, New York, 11743-2787, United States
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Northwell Health South Shore University Hospital
Bay Shore, New York, 11706, United States
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Northwell Health Staten Island University Hospital
Staten Island, New York, 10305-3400, United States
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Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
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Presbyterian Heart Group
Albuquerque, New Mexico, 87106, United States
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Saint Lukes Health System
Kansas City, Missouri, 64111, United States
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Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
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Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705, United States
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The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210-1252, United States
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University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160-8500, United States
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University of South Florida Health (USF)
Tampa, Florida, 33612, United States
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University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
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Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
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Virtua Health
Marlton, New Jersey, 08053, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
Conditions
Explore the condition pages connected to this study.