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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
2026-02
Completion Date
2032-09
Last Updated
2026-02-03
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 (29)
COR Healthcare
Torrance, California, United States
Childrens Hospital Colorado
Aurora, Colorado, United States
Hartford Hosptial
Hartford, Connecticut, United States
University of South Florida Health (USF)
Tampa, Florida, 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
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
North Memorial Health Heart & Vascular Center
Robbinsdale, Minnesota, United States
Saint Lukes Health System
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, 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 Staten Island University Hospital
Staten Island, New York, United States
Duke University Medical Center (DUMC)
Durham, North Carolina, 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
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec, Quebec, Canada