Lead Evaluation for Defibrillation and Reliability Post Approval Study

NCT07005232 · tracked via the Priya Life Science USA tracker

Sponsor

Medtronic

Phase

Observational

Started

2026-01-07

Last updated

2026-08-03

Condition(s) studied

Tachyarrhythmia

Investigational drug(s) / intervention(s)

defibrillation lead

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.

Study 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).

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Complication Survival Rate — 5 years
Estimate OmniaSecure lead-related complication-free survival through 5 years post implant.

Trial sites (73)

Facility	City	Region
The University of Alabama at Birmingham	Birmingham	Alabama
Stanford Hospital & Clinics	Stanford	California
COR Healthcare	Torrance	California
Childrens Hospital Colorado	Aurora	Colorado
Hartford Hosptial	Hartford	Connecticut
Childrens National Medical Center	Washington D.C.	District of Columbia
Heart Rhythm Solutions	Hollywood	Florida
Cardiovascular Institute of Northwest Florida	Panama City	Florida
Heart & Vascular Institute of Florida	Safety Harbor	Florida
Intercoastal Medical Group	Sarasota	Florida
University of South Florida Health (USF)	Tampa	Florida
WellStar Research Institute	Marietta	Georgia
Deaconess Specialty Physicians	Newburgh	Indiana
Iowa Heart Center (West Des Moines IA)	West Des Moines	Iowa
University of Kansas Medical Center Research Institute	Kansas City	Kansas
Saint Elizabeth Healthcare	Edgewood	Kentucky
Norton Heart and Vascular Institute	Louisville	Kentucky
Sparrow Clinical Research Institute	Lansing	Michigan
Michigan Heart	Ypsilanti	Michigan
Metropolitan Cardiology Consultants	Coon Rapids	Minnesota
Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
M Health Fairview University of Minnesota Medical Center - East Bank	Minneapolis	Minnesota
North Memorial Health Heart & Vascular Center	Robbinsdale	Minnesota
Mayo Clinic (Rochester MN)	Rochester	Minnesota
University Hospital (Columbia MO)	Columbia	Missouri
Saint Lukes Health System	Kansas City	Missouri
Washington University School of Medicine	St Louis	Missouri
Nebraska Medicine	Omaha	Nebraska
Virtua Health	Marlton	New Jersey
Presbyterian Heart Group	Albuquerque	New Mexico
Northwell Health South Shore University Hospital	Bay Shore	New York
Northwell Health Huntington Hospital	Huntington	New York
Northwell Health North Shore University Hospital	New York	New York
Long Island Jewish Medical Center	New York	New York
Northwell Health Staten Island University Hospital	Staten Island	New York
Duke University Medical Center (DUMC)	Durham	North Carolina
WakeMed Health & Hospitals	Raleigh	North Carolina
The Christ Hospital Health Network CRD	Cincinnati	Ohio
Cleveland Clinic Foundation	Cleveland	Ohio
The Ohio State University Wexner Medical Center	Columbus	Ohio

+ 33 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07005232 on ClinicalTrials.gov ↗ ← All trials in the USA