TachyarrhythmiaLEADR PASNCT07005232
Lead Evaluation for Defibrillation and Reliability Post Approval Study
An observational study of Tachyarrhythmia, run by Medtronic at 73 sites in 7 countries.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tachyarrhythmia
- What is being tested?
- defibrillation lead
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 73 sitesin 7 countries
- Study dates
- 7 Jan 2026to Sep 2032
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
73 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
73 sites in 7 countries
United States52 sites
Presbyterian Heart Group
Albuquerque, New Mexico, 87106
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Childrens Hospital Colorado
Aurora, Colorado, 80045
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Northwell Health South Shore University Hospital
Bay Shore, New York, 11706
The University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of Virginia Medical Center
Charlottesville, Virginia, 22908
The Christ Hospital Health Network CRD
Cincinnati, Ohio, 45219-2906
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University Hospital (Columbia MO)
Columbia, Missouri, 65212
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210-1252
Metropolitan Cardiology Consultants
Coon Rapids, Minnesota, 55433-4568
Geisinger Medical Center
Danville, Pennsylvania, 17822-9800
Duke University Medical Center (DUMC)
Durham, North Carolina, 27705-4699
Saint Elizabeth Healthcare
Edgewood, Kentucky, 41017
Inova Fairfax Hospital
Fairfax, Virginia, 22031-4867
Consultants in Cardiology (Fort Worth TX)
Fort Worth, Texas, 76104
Heart Center of North Texas
Fort Worth, Texas, 76104
Hartford Hosptial
Hartford, Connecticut, 06106
Heart Rhythm Solutions
Hollywood, Florida, 33021
Northwell Health Huntington Hospital
Huntington, New York, 11743-2787
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160-8500
Saint Lukes Health System
Kansas City, Missouri, 64111
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
Norton Heart and Vascular Institute
Louisville, Kentucky, 40205
WellStar Research Institute
Marietta, Georgia, 30060
Virtua Health
Marlton, New Jersey, 08053
Aurora Cardiovascular Services
Milwaukee, Wisconsin, 53215
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, Minnesota, 55455
Saint Thomas Research Institute
Nashville, Tennessee, 37205
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Northwell Health North Shore University Hospital
New York, New York, 10075
Long Island Jewish Medical Center
New York, New York, 11040
Deaconess Specialty Physicians
Newburgh, Indiana, 47630
Nebraska Medicine
Omaha, Nebraska, 68198-5151
Cardiovascular Institute of Northwest Florida
Panama City, Florida, 32405
The Childrens Hospital of Philadelphia CHOP
Philadelphia, Pennsylvania, 19104
WakeMed Health & Hospitals
Raleigh, North Carolina, 27610
North Memorial Health Heart & Vascular Center
Robbinsdale, Minnesota, 55422-4391
Mayo Clinic (Rochester MN)
Rochester, Minnesota, 55905
Heart & Vascular Institute of Florida
Safety Harbor, Florida, 34695
Intercoastal Medical Group
Sarasota, Florida, 34233
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford Hospital & Clinics
Stanford, California, 64305-2200
Northwell Health Staten Island University Hospital
Staten Island, New York, 10305-3400
University of South Florida Health (USF)
Tampa, Florida, 33612
COR Healthcare
Torrance, California, 90505- 5100
Childrens National Medical Center
Washington D.C., District of Columbia, 20010
Iowa Heart Center (West Des Moines IA)
West Des Moines, Iowa, 50266-8209
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711
Michigan Heart
Ypsilanti, Michigan, 48197
France8 sites
CHRU de Tours - Hôpital Trousseau
Chambray-lès-Tours, 37170
Centre Hospitalier Universitaire de Grenoble - Site Nord
La Tronche, 38700
Centre Hospitalier Régional Universitaire de Lille
Lille, 59037
OC Santé - Clinique du Millénaire
Montpellier, 34960
Hôpital Haut-Lévêque - CHU de Bordeaux
Pessac, 33604
CHU de Rennes - Hôpital Pontchaillou
Rennes, 35033
CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
Rouen, 6229 GW
Clinique Pasteur
Toulouse, 31076
Spain5 sites
Hospital Universitario da Coruña
A Coruña, 15006
Hospital Universitario Virgen de las Nieves
Granada, Granada, 18014
Hospital Universitario 12 de Octubre
Madrid, 28050
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, 38010
Hospital Universitario y Politécnico La Fe
Valencia, 46026
Germany3 sites
Klinikum Bielefeld
Bielefeld, 33604
Saint Vinzenz Hospital Köln
Cologne, 50733
Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
Meerbusch, 40670
United Kingdom3 sites
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, L143PE
Imperial College Healthcare NHS Trust - Hammersmith Hospital
London, W12OHS
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
Southampton
Canada1 site
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec, Quebec, G1V4G5
About this study
Official title: 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).
Read the 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.
- Conditions
- Tachyarrhythmia
- Being tested
- defibrillation lead
- Medical subject headings
- Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
defibrillation leadDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication Survival Rate
Estimate OmniaSecure lead-related complication-free survival through 5 years post implant.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start7 Jan 2026
- Primary completionSep 2032 (estimated)
- Study completionSep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TachyarrhythmiaStudies of the same condition, open and under way.
- More trials run by MedtronicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005232
- Sponsor's protocol ID
- LEADR PAS
- Acronym
- LEADR PAS
- Status last verified
- Jul 2026
- First submitted
- 21 May 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lead Evaluation for Defibrillation and Reliability Post Approval Study (LEADR PAS)
- ClinicalTrials.gov ID
- NCT07005232
- Acronym / sponsor ID
- LEADR PAS / LEADR PAS
- Conditions
- Tachyarrhythmia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- MedtronicIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- Sep 2032 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| defibrillation leadThis 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. | Device | – |
Primary outcome
Complication Survival Rate
Time frame: 5 years
Estimate OmniaSecure lead-related complication-free survival through 5 years post implant.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
73 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tachyarrhythmia, run by Medtronic at 73 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in United States, France, Spain, Germany, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication Survival Rate (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.