New heart lead under watch: 5-Year safety check begins
NCT ID NCT07005232
First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times
Summary
This study follows 2000 people who have or will get the OmniaSecure defibrillation lead, a wire that helps control dangerous heart rhythms. Researchers will track how often the lead causes problems over 5 years. The goal is to make sure the lead is safe and works as expected in everyday use.
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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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Aurora Cardiovascular Services
Milwaukee, Wisconsin, 53215, United States
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CHRU de Tours - Hôpital Trousseau
Chambray-lès-Tours, 37170, France
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CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
Rouen, 6229 GW, France
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CHU de Rennes - Hôpital Pontchaillou
Rennes, 35033, France
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COR Healthcare
Torrance, California, 90505- 5100, United States
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Cardiovascular Institute of Northwest Florida
Panama City, Florida, 32405, United States
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Centre Hospitalier Régional Universitaire de Lille
Lille, 59037, France
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Centre Hospitalier Universitaire de Grenoble - Site Nord
La Tronche, 38700, France
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Childrens Hospital Colorado
Aurora, Colorado, 80045, United States
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Childrens National Medical Center
Washington D.C., District of Columbia, 20010, United States
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Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
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Clinique Pasteur
Toulouse, 31076, France
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Consultants in Cardiology (Fort Worth TX)
Fort Worth, Texas, 76104, United States
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Deaconess Specialty Physicians
Newburgh, Indiana, 47630, 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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Heart & Vascular Institute of Florida
Safety Harbor, Florida, 34695, United States
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Heart Center of North Texas
Fort Worth, Texas, 76104, United States
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Heart Rhythm Solutions
Hollywood, Florida, 33021, United States
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Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
Meerbusch, 40670, Germany
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Hospital Universitario 12 de Octubre
Madrid, 28050, Spain
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Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, 38010, Spain
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Hospital Universitario Virgen de las Nieves
Granada, Granada, 18014, Spain
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Hospital Universitario da Coruña
A Coruña, 15006, Spain
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Hospital Universitario y Politécnico La Fe
Valencia, 46026, Spain
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Hôpital Haut-Lévêque - CHU de Bordeaux
Pessac, 33604, France
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Imperial College Healthcare NHS Trust - Hammersmith Hospital
London, W12OHS, United Kingdom
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Inova Fairfax Hospital
Fairfax, Virginia, 22031-4867, United States
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Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec, Quebec, G1V4G5, Canada
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Intercoastal Medical Group
Sarasota, Florida, 34233, United States
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Iowa Heart Center (West Des Moines IA)
West Des Moines, Iowa, 50266-8209, United States
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Kepler Universitätsklinikum Med Campus III
Linz, 4020, Austria
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Klinikum Bielefeld
Bielefeld, 33604, Germany
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Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
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Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, L143PE, United Kingdom
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Long Island Jewish Medical Center
New York, New York, 11040, United States
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M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, Minnesota, 55455, United States
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Mayo Clinic (Rochester MN)
Rochester, Minnesota, 55905, 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, United States
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Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
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Nebraska Medicine
Omaha, Nebraska, 68198-5151, 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 North Shore University Hospital
New York, New York, 10075, 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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Norton Heart and Vascular Institute
Louisville, Kentucky, 40205, United States
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OC Santé - Clinique du Millénaire
Montpellier, 34960, France
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Presbyterian Heart Group
Albuquerque, New Mexico, 87106, United States
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Saint Elizabeth Healthcare
Edgewood, Kentucky, 41017, United States
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Saint Lukes Health System
Kansas City, Missouri, 64111, United States
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Saint Thomas Research Institute
Nashville, Tennessee, 37205, United States
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Saint Vinzenz Hospital Köln
Cologne, 50733, Germany
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Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
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Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
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Stanford Hospital & Clinics
Stanford, California, 64305-2200, United States
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Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705, United States
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The Childrens Hospital of Philadelphia CHOP
Philadelphia, Pennsylvania, 19104, United States
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The Christ Hospital Health Network CRD
Cincinnati, Ohio, 45219-2906, United States
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The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210-1252, United States
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The University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
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University Hospital (Columbia MO)
Columbia, Missouri, 65212, 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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WakeMed Health & Hospitals
Raleigh, North Carolina, 27610, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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WellStar Research Institute
Marietta, Georgia, 30060, United States
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Other studies related to the condition(s) this trial covers.