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Lead Evaluation for Defibrillation and Reliability Post Approval Study
Sponsor: Medtronic
Summary
Medtronic is sponsoring the LEADR PAS to provide continuing evaluation and periodic reporting of safety and effectiveness of the OmniaSecure™ defibrillation lead following commercial release. The LEADR PAS is conducted within Medtronic's Product Surveillance Registry Platform (NCT01524276).
Official title: Lead Evaluation for Defibrillation and Reliability Post Approval Study (LEADR PAS)
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
2000
Start Date
2026-01-07
Completion Date
2032-09
Last Updated
2026-08-03
Healthy Volunteers
No
Conditions
Interventions
defibrillation lead
This is a device registry for the OmniaSecure™ defibrillation lead. The OmniaSecure lead is a steroid eluting, integrated bipolar, nonretractable screw-in, catheter delivered, transvenous ventricular lead with a Right Ventricular (RV) defibrillation coil electrode. The lead is designed for pacing, sensing, cardioversion, and defibrillation therapies, and has application for patients whom transvenous ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated.
Locations (73)
The University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford Hospital & Clinics
Stanford, California, United States
COR Healthcare
Torrance, California, United States
Childrens Hospital Colorado
Aurora, Colorado, United States
Hartford Hosptial
Hartford, Connecticut, United States
Childrens National Medical Center
Washington D.C., District of Columbia, United States
Heart Rhythm Solutions
Hollywood, Florida, United States
Cardiovascular Institute of Northwest Florida
Panama City, Florida, United States
Heart & Vascular Institute of Florida
Safety Harbor, Florida, United States
Intercoastal Medical Group
Sarasota, Florida, United States
University of South Florida Health (USF)
Tampa, Florida, United States
WellStar Research Institute
Marietta, Georgia, United States
Deaconess Specialty Physicians
Newburgh, Indiana, United States
Iowa Heart Center (West Des Moines IA)
West Des Moines, Iowa, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
Saint Elizabeth Healthcare
Edgewood, Kentucky, United States
Norton Heart and Vascular Institute
Louisville, Kentucky, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
Michigan Heart
Ypsilanti, Michigan, United States
Metropolitan Cardiology Consultants
Coon Rapids, Minnesota, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, Minnesota, United States
North Memorial Health Heart & Vascular Center
Robbinsdale, Minnesota, United States
Mayo Clinic (Rochester MN)
Rochester, Minnesota, United States
University Hospital (Columbia MO)
Columbia, Missouri, United States
Saint Lukes Health System
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Nebraska Medicine
Omaha, Nebraska, United States
Virtua Health
Marlton, New Jersey, United States
Presbyterian Heart Group
Albuquerque, New Mexico, United States
Northwell Health South Shore University Hospital
Bay Shore, New York, United States
Northwell Health Huntington Hospital
Huntington, New York, United States
Northwell Health North Shore University Hospital
New York, New York, United States
Long Island Jewish Medical Center
New York, New York, United States
Northwell Health Staten Island University Hospital
Staten Island, New York, United States
Duke University Medical Center (DUMC)
Durham, North Carolina, United States
WakeMed Health & Hospitals
Raleigh, North Carolina, United States
The Christ Hospital Health Network CRD
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
The Childrens Hospital of Philadelphia CHOP
Philadelphia, Pennsylvania, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
Saint Thomas Research Institute
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Consultants in Cardiology (Fort Worth TX)
Fort Worth, Texas, United States
Heart Center of North Texas
Fort Worth, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Fairfax, Virginia, United States
Aurora Cardiovascular Services
Milwaukee, Wisconsin, United States
Kepler Universitätsklinikum Med Campus III
Linz, Austria
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec, Quebec, Canada
CHRU de Tours - Hôpital Trousseau
Chambray-lès-Tours, France
Centre Hospitalier Universitaire de Grenoble - Site Nord
La Tronche, France
Centre Hospitalier Régional Universitaire de Lille
Lille, France
OC Santé - Clinique du Millénaire
Montpellier, France
Hôpital Haut-Lévêque - CHU de Bordeaux
Pessac, France
CHU de Rennes - Hôpital Pontchaillou
Rennes, France
CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
Rouen, France
Clinique Pasteur
Toulouse, France
Klinikum Bielefeld
Bielefeld, Germany
Saint Vinzenz Hospital Köln
Cologne, Germany
Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
Meerbusch, Germany
Hospital Universitario Virgen de las Nieves
Granada, Granada, Spain
Hospital Universitario da Coruña
A Coruña, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, United Kingdom
Imperial College Healthcare NHS Trust - Hammersmith Hospital
London, United Kingdom
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom