Lead Evaluation for Defibrillation and Reliability Post Approval Study

Enrolling by invitation

Conditions studied: Tachyarrhythmia

In brief

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 facts

Study ID

NCT07005232

Run by

Medtronic

People needed

2000

Starts

2026-01-07

Expected to finish

2032-09-01

Last updated by the study team

2026-08-03

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford Hospital & Clinics — Stanford, California, United States
• COR Healthcare — Torrance, California, United States
• Childrens Hospital Colorado — Aurora, Colorado, United States
• Hartford Hosptial — Hartford, Connecticut, United States
• Childrens National Medical Center — Washington D.C., District of Columbia, United States
• Heart Rhythm Solutions — Hollywood, Florida, United States
• Cardiovascular Institute of Northwest Florida — Panama City, Florida, United States
• Heart & Vascular Institute of Florida — Safety Harbor, Florida, United States
• Intercoastal Medical Group — Sarasota, Florida, United States
• University of South Florida Health (USF) — Tampa, Florida, United States
• WellStar Research Institute — Marietta, Georgia, United States
• Deaconess Specialty Physicians — Newburgh, Indiana, United States
• Iowa Heart Center (West Des Moines IA) — West Des Moines, Iowa, United States
• University of Kansas Medical Center Research Institute — Kansas City, Kansas, United States
• Saint Elizabeth Healthcare — Edgewood, Kentucky, United States
• Norton Heart and Vascular Institute — Louisville, Kentucky, United States
• Sparrow Clinical Research Institute — Lansing, Michigan, United States
• Michigan Heart — Ypsilanti, Michigan, United States
• Metropolitan Cardiology Consultants — Coon Rapids, Minnesota, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• M Health Fairview University of Minnesota Medical Center - East Bank — Minneapolis, Minnesota, United States
• North Memorial Health Heart & Vascular Center — Robbinsdale, Minnesota, United States
• Mayo Clinic (Rochester MN) — Rochester, Minnesota, United States
• University Hospital (Columbia MO) — Columbia, Missouri, United States
• The University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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