NCT07005232

Lead Evaluation for Defibrillation and Reliability Post Approval Study

Lead Evaluation for Defibrillation and Reliability Post Approval Study (LEADR PAS)

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Medtronic · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Detailed description

The LEADR PAS is a global, prospective, observational, multi-site registry study. This study is conducted within Medtronic's Product Surveillance Registry Platform (NCT01524276). Eligibility for enrollment is based on market release dates for the OmniaSecure™ defibrillation lead within the geography in which the subject is enrolled. Patients enrolled in LEADR PAS will be prospectively followed for the lifetime of device post-implant or until registry closure, patient death, or patient exit from the registry (i.e., withdrawal of consent). Successfully implanted patients are expected to have scheduled follow-up visits per routine clinical care, at least annually, or as prompted by reportable adverse events. The primary objective analysis will occur when 500 patients reach 5 years of follow-up. The total estimated registry duration is through lifetime of device.

Conditions

• Tachyarrhythmia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2032-09-01
• Completion: 2032-09-01
• First posted: 2025-06-05
• Last updated: 2026-02-03

Locations

29 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study