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

Medtronic

Status: Invitation-only

Conditions: Tachyarrhythmia

Treatments: Device: defibrillation lead

Study type: Observational

Funder types: Industry

Identifiers

NCT07005232

LEADR PAS

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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