Lead Evaluation for Defibrillation and Reliability Post Approval Study

Conditions

• Tachyarrhythmia

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• defibrillation lead — 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

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).

Key Dates

First listed

Jun 5, 2025

Start date

Jan 7, 2026

Status verified

Jul 2026

Primary completion

Sep 30, 2032

Completion

Sep 30, 2032

Study Design

Enrollment

2,000 participants (estimated)

Primary Outcome Measure

Complication Survival Rate [ Time Frame: 5 years ]

Locations (52)

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