Lead Evaluation for Defibrillation and Reliability Post Approval Study

• Conditions: Tachyarrhythmia

• Registration Number: NCT07005232
• Lead Sponsor: Medtronic

Brief 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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-21
• Study First Submitted QC: 2025-06-02
• Study First Posted: 2025-06-05
• Last Update Submitted: 2025-10-17
• Last Update Posted: 2025-10-21
• Study Start: 2026-02-01
• Primary Completion: 2032-09
• Study Completion: 2032-09-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
• Patient has, or is intended to receive or be treated with an OmniaSecure™ defibrillation lead.
• Patient is consented prior to or within 30 days of the therapy received or consented as continuation from the LEADR Pivotal study

Exclusion Criteria

• Patient who is, or is expected to be, inaccessible for follow-up
• Patient is excluded by local local law
• Patient is currently enrolled or plans to enroll in any concurrent drug and/or device study that may confound the Product Surveillence Registyr (PSR) results

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complication Survival Rate	5 years	Estimate OmniaSecure lead-related complication-free survival through 5 years post implant.

Trial Locations

Locations (13)

Hartford Hosptial; 🇺🇸 Hartford, Connecticut, United States

Minneapolis Heart Institute Foundation; 🇺🇸 Minneapolis, Minnesota, United States

Saint Lukes Health System; 🇺🇸 Kansas City, Missouri, United States

Washington University School of Medicine; 🇺🇸 St Louis, Missouri, United States

Virtua Health; 🇺🇸 Marlton, New Jersey, United States

Presbyterian Heart Group; 🇺🇸 Albuquerque, New Mexico, United States

Northwell Health South Shore University Hospital; 🇺🇸 Bay Shore, New York, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Lehigh Valley Health Network; 🇺🇸 Allentown, Pennsylvania, United States

Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

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