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TachyarrhythmiaDevice

What this study is

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).

What's being tested

  • defibrillation lead

    Intervention · DEVICE

    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 details

Official title
Lead Evaluation for Defibrillation and Reliability Post Approval Study (LEADR PAS)
Sponsor
Medtronic
Conditions
Tachyarrhythmia
Enrolling
2,000 people
Starts
2026-01-07
Est. completion
2032-09
Record
View on ClinicalTrials.gov ↗