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

April 24, 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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
  • France
      • Montpellier, France, 34960
        • OC Santé - Clinique du Millénaire
  • Spain
    • Granada
      • Granada, Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • The University of Alabama at Birmingham
    • California
      • 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
      • 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
    • 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
      • 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
      • 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
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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