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Enrolling by invitation No phase listed Observational

Lead Evaluation for Defibrillation and Reliability Post Approval Study

ClinicalTrials.gov ID: NCT07005232

Public ClinicalTrials.gov record NCT07005232. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 9:24 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT07005232
Recruitment status
Enrolling by invitation
Study type
Observational
Phase
Not listed
Lead sponsor
Medtronic
Industry
Enrollment
2,000 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 7, 2026 (Actual)
Primary completion
Sep 2032 (Estimated)
Completion
Sep 2032 (Estimated)
Last update posted
Aug 3, 2026

2026 – 2032

United States locations

U.S. sites
52
U.S. states
25
U.S. cities
48
Facility City State ZIP Site status
The University of Alabama at Birmingham Birmingham Alabama 35233 —
Stanford Hospital & Clinics Stanford California 64305-2200 —
COR Healthcare Torrance California 90505- 5100 —
Childrens Hospital Colorado Aurora Colorado 80045 —
Hartford Hosptial Hartford Connecticut 06106 —
Childrens National Medical Center Washington D.C. District of Columbia 20010 —
Heart Rhythm Solutions Hollywood Florida 33021 —
Cardiovascular Institute of Northwest Florida Panama City Florida 32405 —
Heart & Vascular Institute of Florida Safety Harbor Florida 34695 —
Intercoastal Medical Group Sarasota Florida 34233 —
University of South Florida Health (USF) Tampa Florida 33612 —
WellStar Research Institute Marietta Georgia 30060 —
Deaconess Specialty Physicians Newburgh Indiana 47630 —
Iowa Heart Center (West Des Moines IA) West Des Moines Iowa 50266-8209 —
University of Kansas Medical Center Research Institute Kansas City Kansas 66160-8500 —
Saint Elizabeth Healthcare Edgewood Kentucky 41017 —
Norton Heart and Vascular Institute Louisville Kentucky 40205 —
Sparrow Clinical Research Institute Lansing Michigan 48912 —
Michigan Heart Ypsilanti Michigan 48197 —
Metropolitan Cardiology Consultants Coon Rapids Minnesota 55433-4568 —
Minneapolis Heart Institute Foundation Minneapolis Minnesota 55407 —
M Health Fairview University of Minnesota Medical Center - East Bank Minneapolis Minnesota 55455 —
North Memorial Health Heart & Vascular Center Robbinsdale Minnesota 55422-4391 —
Mayo Clinic (Rochester MN) Rochester Minnesota 55905 —
University Hospital (Columbia MO) Columbia Missouri 65212 —
Saint Lukes Health System Kansas City Missouri 64111 —
Washington University School of Medicine St Louis Missouri 63110 —
Nebraska Medicine Omaha Nebraska 68198-5151 —
Virtua Health Marlton New Jersey 08053 —
Presbyterian Heart Group Albuquerque New Mexico 87106 —
Northwell Health South Shore University Hospital Bay Shore New York 11706 —
Northwell Health Huntington Hospital Huntington New York 11743-2787 —
Northwell Health North Shore University Hospital New York New York 10075 —
Long Island Jewish Medical Center New York New York 11040 —
Northwell Health Staten Island University Hospital Staten Island New York 10305-3400 —
Duke University Medical Center (DUMC) Durham North Carolina 27705-4699 —
WakeMed Health & Hospitals Raleigh North Carolina 27610 —
The Christ Hospital Health Network CRD Cincinnati Ohio 45219-2906 —
Cleveland Clinic Foundation Cleveland Ohio 44195 —
The Ohio State University Wexner Medical Center Columbus Ohio 43210-1252 —
Lehigh Valley Health Network Allentown Pennsylvania 18103 —
Geisinger Medical Center Danville Pennsylvania 17822-9800 —
The Childrens Hospital of Philadelphia CHOP Philadelphia Pennsylvania 19104 —
Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania 18711 —
Saint Thomas Research Institute Nashville Tennessee 37205 —
Vanderbilt University Medical Center Nashville Tennessee 37232 —
Texas Cardiac Arrhythmia Research Foundation Austin Texas 78705 —
Consultants in Cardiology (Fort Worth TX) Fort Worth Texas 76104 —
Heart Center of North Texas Fort Worth Texas 76104 —
University of Virginia Medical Center Charlottesville Virginia 22908 —
Inova Fairfax Hospital Fairfax Virginia 22031-4867 —
Aurora Cardiovascular Services Milwaukee Wisconsin 53215 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07005232, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 3, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07005232 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →