Lead Evaluation for Defibrillation and Reliability Post Approval Study

NCT07005232 | Enrolling By Invitation FDA Device

• 1 other identifier: LEADR PAS
• Study Type: observational
• Target: 2,000
• Locations: 7 countries
• Sites: 73

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).

Conditions

Tachyarrhythmia

Outcome Measures

Primary Outcomes (1)

• Complication Survival Rate

  Estimate OmniaSecure lead-related complication-free survival through 5 years post implant.

  5 years

Interventions

defibrillation lead DEVICE

This is a device registry for the OmniaSecure™ defibrillation lead. The OmniaSecure lead is a steroid eluting, integrated bipolar, nonretractable screw-in, catheter delivered, transvenous ventricular lead with a Right Ventricular (RV) defibrillation coil electrode. The lead is designed for pacing, sensing, cardioversion, and defibrillation therapies, and has application for patients whom transvenous ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Medtronic: lead

Study Sites (73)

The University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Stanford Hospital & Clinics

Stanford, California, 64305-2200, United States

Location

COR Healthcare

Torrance, California, 90505- 5100, United States

Location

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Hartford Hosptial

Hartford, Connecticut, 06106, United States

Location

Childrens National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Heart Rhythm Solutions

Hollywood, Florida, 33021, United States

Location

Cardiovascular Institute of Northwest Florida

Panama City, Florida, 32405, United States

Location

Heart & Vascular Institute of Florida

Safety Harbor, Florida, 34695, United States

Location

Intercoastal Medical Group

Sarasota, Florida, 34233, United States

Location

University of South Florida Health (USF)

Tampa, Florida, 33612, United States

Location

WellStar Research Institute

Marietta, Georgia, 30060, United States

Location

Deaconess Specialty Physicians

Newburgh, Indiana, 47630, United States

Location

Iowa Heart Center (West Des Moines IA)

West Des Moines, Iowa, 50266-8209, United States

Location

University of Kansas Medical Center Research Institute

Kansas City, Kansas, 66160-8500, United States

Location

Saint Elizabeth Healthcare

Edgewood, Kentucky, 41017, United States

Location

Norton Heart and Vascular Institute

Louisville, Kentucky, 40205, United States

Location

Sparrow Clinical Research Institute

Lansing, Michigan, 48912, United States

Location

Michigan Heart

Ypsilanti, Michigan, 48197, United States

Location

Metropolitan Cardiology Consultants

Coon Rapids, Minnesota, 55433-4568, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

M Health Fairview University of Minnesota Medical Center - East Bank

Minneapolis, Minnesota, 55455, United States

Location

North Memorial Health Heart & Vascular Center

Robbinsdale, Minnesota, 55422-4391, United States

Location

Mayo Clinic (Rochester MN)

Rochester, Minnesota, 55905, United States

Location

University Hospital (Columbia MO)

Columbia, Missouri, 65212, United States

Location

Saint Lukes Health System

Kansas City, Missouri, 64111, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Nebraska Medicine

Omaha, Nebraska, 68198-5151, United States

Location

Virtua Health

Marlton, New Jersey, 08053, United States

Location

Presbyterian Heart Group

Albuquerque, New Mexico, 87106, United States

Location

Northwell Health South Shore University Hospital

Bay Shore, New York, 11706, United States

Location

Northwell Health Huntington Hospital

Huntington, New York, 11743-2787, United States

Location

Northwell Health North Shore University Hospital

New York, New York, 10075, United States

Location

Long Island Jewish Medical Center

New York, New York, 11040, United States

Location

Northwell Health Staten Island University Hospital

Staten Island, New York, 10305-3400, United States

Location

Duke University Medical Center (DUMC)

Durham, North Carolina, 27705-4699, United States

Location

WakeMed Health & Hospitals

Raleigh, North Carolina, 27610, United States

Location

The Christ Hospital Health Network CRD

Cincinnati, Ohio, 45219-2906, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210-1252, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-9800, United States

Location

The Childrens Hospital of Philadelphia CHOP

Philadelphia, Pennsylvania, 19104, United States

Location

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Saint Thomas Research Institute

Nashville, Tennessee, 37205, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Consultants in Cardiology (Fort Worth TX)

Fort Worth, Texas, 76104, United States

Location

Heart Center of North Texas

Fort Worth, Texas, 76104, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Inova Fairfax Hospital

Fairfax, Virginia, 22031-4867, United States

Location

Aurora Cardiovascular Services

Milwaukee, Wisconsin, 53215, United States

Location

Kepler Universitätsklinikum Med Campus III

Linz, 4020, Austria

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Québec, Quebec, G1V4G5, Canada

Location

CHRU de Tours - Hôpital Trousseau

Chambray-lès-Tours, 37170, France

Location

Centre Hospitalier Universitaire de Grenoble - Site Nord

La Tronche, 38700, France

Location

Centre Hospitalier Régional Universitaire de Lille

Lille, 59037, France

Location

OC Santé - Clinique du Millénaire

Montpellier, 34960, France

Location

Hôpital Haut-Lévêque - CHU de Bordeaux

Pessac, 33604, France

Location

CHU de Rennes - Hôpital Pontchaillou

Rennes, 35033, France

Location

CHU Hôpitaux de Rouen - Hôpital Charles Nicolle

Rouen, 6229 GW, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Klinikum Bielefeld

Bielefeld, 33604, Germany

Location

Saint Vinzenz Hospital Köln

Cologne, 50733, Germany

Location

Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum

Meerbusch, 40670, Germany

Location

Hospital Universitario Virgen de las Nieves

Granada, Granada, 18014, Spain

Location

Hospital Universitario da Coruña

A Coruña, 15006, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28050, Spain

Location

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, 38010, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

Location

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, L143PE, United Kingdom

Location

Imperial College Healthcare NHS Trust - Hammersmith Hospital

London, W12OHS, United Kingdom

Location

Southampton General Hospital - University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 5, 2025
• Study Start: January 7, 2026
• Primary Completion (Estimated): September 1, 2032
• Study Completion (Estimated): September 1, 2032
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8); ES (5); US (52); CA (1); DE (3); GB (3); AU (1)