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New heart lead under watch: 5-Year safety check begins

NCT ID NCT07005232

Disease control Sponsor: Medtronic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This study follows 2000 people who have or will get the OmniaSecure defibrillation lead, a wire that helps control dangerous heart rhythms. Researchers will track how often the lead causes problems over 5 years. The goal is to make sure the lead is safe and works as expected in everyday use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Sep 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cardiac rhythm disease Tachycardia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tachyarrhythmia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    73 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aurora Cardiovascular Services

    Milwaukee, Wisconsin, 53215, United States

  • CHRU de Tours - Hôpital Trousseau

    Chambray-lès-Tours, 37170, France

  • CHU Hôpitaux de Rouen - Hôpital Charles Nicolle

    Rouen, 6229 GW, France

  • CHU de Rennes - Hôpital Pontchaillou

    Rennes, 35033, France

  • COR Healthcare

    Torrance, California, 90505- 5100, United States

  • Cardiovascular Institute of Northwest Florida

    Panama City, Florida, 32405, United States

  • Centre Hospitalier Régional Universitaire de Lille

    Lille, 59037, France

  • Centre Hospitalier Universitaire de Grenoble - Site Nord

    La Tronche, 38700, France

  • Childrens Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Childrens National Medical Center

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

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Clinique Pasteur

    Toulouse, 31076, France

  • Consultants in Cardiology (Fort Worth TX)

    Fort Worth, Texas, 76104, United States

  • Deaconess Specialty Physicians

    Newburgh, Indiana, 47630, United States

  • Duke University Medical Center (DUMC)

    Durham, North Carolina, 27705-4699, United States

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-9800, United States

  • Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711, United States

  • Hartford Hosptial

    Hartford, Connecticut, 06106, United States

  • Heart & Vascular Institute of Florida

    Safety Harbor, Florida, 34695, United States

  • Heart Center of North Texas

    Fort Worth, Texas, 76104, United States

  • Heart Rhythm Solutions

    Hollywood, Florida, 33021, United States

  • Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum

    Meerbusch, 40670, Germany

  • Hospital Universitario 12 de Octubre

    Madrid, 28050, Spain

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, 38010, Spain

  • Hospital Universitario Virgen de las Nieves

    Granada, Granada, 18014, Spain

  • Hospital Universitario da Coruña

    A Coruña, 15006, Spain

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46026, Spain

  • Hôpital Haut-Lévêque - CHU de Bordeaux

    Pessac, 33604, France

  • Imperial College Healthcare NHS Trust - Hammersmith Hospital

    London, W12OHS, United Kingdom

  • Inova Fairfax Hospital

    Fairfax, Virginia, 22031-4867, United States

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

    Québec, Quebec, G1V4G5, Canada

  • Intercoastal Medical Group

    Sarasota, Florida, 34233, United States

  • Iowa Heart Center (West Des Moines IA)

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

  • Kepler Universitätsklinikum Med Campus III

    Linz, 4020, Austria

  • Klinikum Bielefeld

    Bielefeld, 33604, Germany

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103, United States

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    Liverpool, L143PE, United Kingdom

  • Long Island Jewish Medical Center

    New York, New York, 11040, United States

  • M Health Fairview University of Minnesota Medical Center - East Bank

    Minneapolis, Minnesota, 55455, United States

  • Mayo Clinic (Rochester MN)

    Rochester, Minnesota, 55905, United States

  • Metropolitan Cardiology Consultants

    Coon Rapids, Minnesota, 55433-4568, United States

  • Michigan Heart

    Ypsilanti, Michigan, 48197, United States

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407, United States

  • Nebraska Medicine

    Omaha, Nebraska, 68198-5151, United States

  • North Memorial Health Heart & Vascular Center

    Robbinsdale, Minnesota, 55422-4391, United States

  • Northwell Health Huntington Hospital

    Huntington, New York, 11743-2787, United States

  • Northwell Health North Shore University Hospital

    New York, New York, 10075, United States

  • Northwell Health South Shore University Hospital

    Bay Shore, New York, 11706, United States

  • Northwell Health Staten Island University Hospital

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

  • Norton Heart and Vascular Institute

    Louisville, Kentucky, 40205, United States

  • OC Santé - Clinique du Millénaire

    Montpellier, 34960, France

  • Presbyterian Heart Group

    Albuquerque, New Mexico, 87106, United States

  • Saint Elizabeth Healthcare

    Edgewood, Kentucky, 41017, United States

  • Saint Lukes Health System

    Kansas City, Missouri, 64111, United States

  • Saint Thomas Research Institute

    Nashville, Tennessee, 37205, United States

  • Saint Vinzenz Hospital Köln

    Cologne, 50733, Germany

  • Southampton General Hospital - University Hospital Southampton NHS Foundation Trust

    Southampton, United Kingdom

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912, United States

  • Stanford Hospital & Clinics

    Stanford, California, 64305-2200, United States

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705, United States

  • The Childrens Hospital of Philadelphia CHOP

    Philadelphia, Pennsylvania, 19104, United States

  • The Christ Hospital Health Network CRD

    Cincinnati, Ohio, 45219-2906, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210-1252, United States

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University Hospital (Columbia MO)

    Columbia, Missouri, 65212, United States

  • University of Kansas Medical Center Research Institute

    Kansas City, Kansas, 66160-8500, United States

  • University of South Florida Health (USF)

    Tampa, Florida, 33612, United States

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Virtua Health

    Marlton, New Jersey, 08053, United States

  • WakeMed Health & Hospitals

    Raleigh, North Carolina, 27610, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • WellStar Research Institute

    Marietta, Georgia, 30060, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.