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Clinical Trials in France / NCT07005232
Enrolling by invitation Observational

Lead Evaluation for Defibrillation and Reliability Post Approval Study

NCT07005232 · tracked via the Priya Life Science France 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
No
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)

FacilityCityRegionStatus
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.

More Medtronic trials in France

Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products Recruiting
Product Surveillance Registry Recruiting
Enlighten Study: The EV-ICD Post Approval Registry Active, not recruiting
Micra Transcatheter Pacing System Post-Approval Registry Active, not recruiting
Personalized Therapy Study - HFRS (TriageHF) Post Approval Study Active, not recruiting
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 France