Lead Evaluation for Defibrillation and Reliability Post Approval Study
LEADR PAS
1 other identifier
observational
2,000
4 countries
49
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2026
Longer than P75 for all trials
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2025
CompletedFirst Posted
Study publicly available on registry
June 5, 2025
CompletedStudy Start
First participant enrolled
January 7, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2032
April 27, 2026
May 1, 2025
6.7 years
May 21, 2025
April 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Complication Survival Rate
Estimate OmniaSecure lead-related complication-free survival through 5 years post implant.
5 years
Interventions
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.
Eligibility Criteria
Geographies with regulatory approval for the OmniaSecure™ defibrillation lead are eligible to enroll patients (see locations section). Any patient receiving an implant of the OmniaSecure lead, based on the treating physician's medical discretion, is eligible for enrollment into the study (patients previously enrolled in the pre-market clinical trial with a clinical model 093000 OmniaSecure lead may also be eligible for continued follow-up into the OmniaSecure PAS). In geographies where applicable, OmniaSecure PAS will include adolescent pediatric patients, who are at least 30 kg and are also at least 12 years of age, whose cardiac anatomy is conducive to RV coil placement.
You may qualify if:
- Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- Patient has, or is intended to receive or be treated with an OmniaSecure™ defibrillation lead.
- Patient is consented prior to or within 30 days of the therapy received or consented as continuation from the LEADR Pivotal study
You may not qualify if:
- Patient who is, or is expected to be, inaccessible for follow-up
- Patient is excluded by local local law
- Patient is currently enrolled or plans to enroll in any concurrent drug and/or device study that may confound the Product Surveillence Registyr (PSR) results
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtroniclead
Study Sites (49)
The University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
COR Healthcare
Torrance, California, 90505- 5100, United States
Childrens Hospital Colorado
Aurora, Colorado, 80045, United States
Hartford Hosptial
Hartford, Connecticut, 06106, United States
Childrens National Medical Center
Washington D.C., District of Columbia, 20010, United States
Heart Rhythm Solutions
Hollywood, Florida, 33021, United States
Cardiovascular Institute of Northwest Florida
Panama City, Florida, 32405, United States
Heart & Vascular Institute of Florida
Safety Harbor, Florida, 34695, United States
University of South Florida Health (USF)
Tampa, Florida, 33612, United States
WellStar Research Institute
Marietta, Georgia, 30060, United States
Deaconess Specialty Physicians
Newburgh, Indiana, 47630, United States
Iowa Heart Center (West Des Moines IA)
West Des Moines, Iowa, 50266-8209, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160-8500, United States
Saint Elizabeth Healthcare
Edgewood, Kentucky, 41017, United States
Norton Heart and Vascular Institute
Louisville, Kentucky, 40205, United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
Michigan Heart
Ypsilanti, Michigan, 48197, United States
Metropolitan Cardiology Consultants
Coon Rapids, Minnesota, 55433-4568, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, Minnesota, 55455, United States
North Memorial Health Heart & Vascular Center
Robbinsdale, Minnesota, 55422-4391, United States
Mayo Clinic (Rochester MN)
Rochester, Minnesota, 55905, United States
University Hospital (Columbia MO)
Columbia, Missouri, 65212, United States
Saint Lukes Health System
Kansas City, Missouri, 64111, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Virtua Health
Marlton, New Jersey, 08053, United States
Presbyterian Heart Group
Albuquerque, New Mexico, 87106, United States
Northwell Health South Shore University Hospital
Bay Shore, New York, 11706, United States
Northwell Health Huntington Hospital
Huntington, New York, 11743-2787, United States
Northwell Health North Shore University Hospital
New York, New York, 10075, United States
Long Island Jewish Medical Center
New York, New York, 11040, United States
Northwell Health Staten Island University Hospital
Staten Island, New York, 10305-3400, United States
Duke University Medical Center (DUMC)
Durham, North Carolina, 27705-4699, United States
WakeMed Health & Hospitals
Raleigh, North Carolina, 27610, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210-1252, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-9800, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
Saint Thomas Research Institute
Nashville, Tennessee, 37205, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705, United States
Consultants in Cardiology (Fort Worth TX)
Fort Worth, Texas, 76104, United States
Heart Center of North Texas
Fort Worth, Texas, 76104, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Aurora Cardiovascular Services
Milwaukee, Wisconsin, 53215, United States
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec, Quebec, G1V4G5, Canada
OC Santé - Clinique du Millénaire
Montpellier, 34960, France
Hospital Universitario Virgen de las Nieves
Granada, Granada, 18014, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 15 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2025
First Posted
June 5, 2025
Study Start
January 7, 2026
Primary Completion (Estimated)
September 1, 2032
Study Completion (Estimated)
September 1, 2032
Last Updated
April 27, 2026
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share