Lead Evaluation for Defibrillation and Reliability Post Approval Study

Overview

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).

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

Interventions

Eligibility

Locations (29)

Outcomes