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

July 31, 2026 updated by: Medtronic

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

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).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4020
        • Kepler Universitatsklinikum Med Campus III
  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
  • France
      • Chambray-lès-Tours, France, 37170
        • CHRU de Tours - Hôpital Trousseau
      • La Tronche, France, 38700
        • Centre Hospitalier Universitaire de Grenoble - Site Nord
      • Lille, France, 59037
        • Centre Hospitalier Regional Universitaire de Lille
      • Montpellier, France, 34960
        • OC Santé - Clinique du Millénaire
      • Pessac, France, 33604
        • Hôpital Haut-Lévêque - CHU de Bordeaux
      • Rennes, France, 35033
        • CHU De Rennes - Hôpital Pontchaillou
      • Rouen, France, 6229 GW
        • CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
      • Toulouse, France, 31076
        • Clinique Pasteur
  • Germany
      • Bielefeld, Germany, 33604
        • Klinikum Bielefeld
      • Cologne, Germany, 50733
        • Saint Vinzenz Hospital Köln
      • Meerbusch, Germany, 40670
        • Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
  • Spain
      • A Coruña, Spain, 15006
        • Hospital Universitario da Coruña
      • Madrid, Spain, 28050
        • Hospital Universitario 12 de Octubre
      • Santa Cruz de Tenerife, Spain, 38010
        • Hospital Universitario Nuestra Señora de Candelaria
      • Valencia, Spain, 46026
        • Hospital Universitario y Politécnico La Fe
    • Granada
      • Granada, Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
  • United Kingdom
      • Liverpool, United Kingdom, L143PE
        • Liverpool Heart and Chest Hospital NHS Foundation Trust
      • London, United Kingdom, W12OHS
        • Imperial College Healthcare NHS Trust - Hammersmith Hospital
      • Southampton, United Kingdom
        • Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • The University of Alabama at Birmingham
    • California
      • Stanford, California, United States, 64305-2200
        • Stanford Hospital & Clinics
      • Torrance, California, United States, 90505- 5100
        • COR Healthcare
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Childrens Hospital Colorado
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Hartford Hosptial
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Childrens National Medical Center
    • Florida
      • Hollywood, Florida, United States, 33021
        • Heart Rhythm Solutions
      • Panama City, Florida, United States, 32405
        • Cardiovascular Institute of Northwest Florida
      • Safety Harbor, Florida, United States, 34695
        • Heart & Vascular Institute of Florida
      • Sarasota, Florida, United States, 34233
        • Intercoastal Medical Group
      • Tampa, Florida, United States, 33612
        • University of South Florida Health (USF)
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Wellstar Research Institute
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • Deaconess Specialty Physicians
    • Iowa
      • West Des Moines, Iowa, United States, 50266-8209
        • Iowa Heart Center (West Des Moines IA)
    • Kansas
      • Kansas City, Kansas, United States, 66160-8500
        • University of Kansas Medical Center Research Institute
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Saint Elizabeth Healthcare
      • Louisville, Kentucky, United States, 40205
        • Norton Heart and Vascular Institute
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Sparrow Clinical Research Institute
      • Ypsilanti, Michigan, United States, 48197
        • Michigan Heart
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433-4568
        • Metropolitan Cardiology Consultants
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
      • Minneapolis, Minnesota, United States, 55455
        • M Health Fairview University of Minnesota Medical Center - East Bank
      • Robbinsdale, Minnesota, United States, 55422-4391
        • North Memorial Health Heart & Vascular Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic (Rochester MN)
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University Hospital (Columbia MO)
      • Kansas City, Missouri, United States, 64111
        • Saint Lukes Health System
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68198-5151
        • Nebraska Medicine
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Virtua Health
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Presbyterian Heart Group
    • New York
      • Bay Shore, New York, United States, 11706
        • Northwell Health South Shore University Hospital
      • Huntington, New York, United States, 11743-2787
        • Northwell Health Huntington Hospital
      • New York, New York, United States, 11040
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10075
        • Northwell Health North Shore University Hospital
      • Staten Island, New York, United States, 10305-3400
        • Northwell Health Staten Island University Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27705-4699
        • Duke University Medical Center (DUMC)
      • Raleigh, North Carolina, United States, 27610
        • WakeMed Health & Hospitals
    • Ohio
      • Cincinnati, Ohio, United States, 45219-2906
        • The Christ Hospital Health Network CRD
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210-1252
        • The Ohio State University Wexner Medical Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Health Network
      • Danville, Pennsylvania, United States, 17822-9800
        • Geisinger Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • The Childrens Hospital of Philadelphia CHOP
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37205
        • Saint Thomas Research Institute
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Research Foundation
      • Fort Worth, Texas, United States, 76104
        • Heart Center of North Texas
      • Fort Worth, Texas, United States, 76104
        • Consultants in Cardiology (Fort Worth TX)
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Medical Center
      • Fairfax, Virginia, United States, 22031-4867
        • INOVA Fairfax Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Cardiovascular Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Geographies with regulatory approval for the OmniaSecure™ defibrillation lead are eligible to enroll patients (see locations section). Any patient receiving an implant of the OmniaSecure lead, based on the treating physician's medical discretion, is eligible for enrollment into the study (patients previously enrolled in the pre-market clinical trial with a clinical model 093000 OmniaSecure lead may also be eligible for continued follow-up into the OmniaSecure PAS). In geographies where applicable, OmniaSecure PAS will include adolescent pediatric patients, who are at least 30 kg and are also at least 12 years of age, whose cardiac anatomy is conducive to RV coil placement.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication Survival Rate
Time Frame: 5 years
Estimate OmniaSecure lead-related complication-free survival through 5 years post implant.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2026

Primary Completion (Estimated)

September 1, 2032

Study Completion (Estimated)

September 1, 2032

Study Registration Dates

First Submitted

May 21, 2025

First Submitted That Met QC Criteria

June 2, 2025

First Posted (Actual)

June 5, 2025

Study Record Updates

Last Update Posted (Actual)

August 3, 2026

Last Update Submitted That Met QC Criteria

July 31, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEADR PAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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