Lead Evaluation for Defibrillation and Reliability Post Approval Study

Enrolling by invitationOBSERVATIONAL
Enrollment

2,000

Participants

Timeline

Start Date

February 28, 2026

Primary Completion Date

September 30, 2032

Study Completion Date

September 30, 2032

Conditions
Tachyarrhythmia
Interventions
DEVICE

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.

Trial Locations (13)

11706

Northwell Health South Shore University Hospital, Bay Shore

18103

Lehigh Valley Health Network, Allentown

19107

Pennsylvania Hospital, Philadelphia

22908

University of Virginia Medical Center, Charlottesville

37232

Vanderbilt University Medical Center, Nashville

44195

Cleveland Clinic Foundation, Cleveland

55407

Minneapolis Heart Institute Foundation, Minneapolis

63110

Washington University School of Medicine, St Louis

64111

Saint Lukes Health System, Kansas City

78705

Texas Cardiac Arrhythmia Research Foundation, Austin

87106

Presbyterian Heart Group, Albuquerque

06106

Hartford Hosptial, Hartford

08053

Virtua Health, Marlton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Medtronic

INDUSTRY