Lead Evaluation for Defibrillation and Reliability Post Approval Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: defibrillation lead.
- Who it may be relevant to
- Registry conditions: Tachyarrhythmia. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Austria, Canada, France, Germany +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Lead Evaluation for Defibrillation and Reliability Post Approval Study (LEADR PAS)
Overview
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.
Interventions
- Device defibrillation lead
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.
Primary outcome measures
- Complication Survival Rate [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 52 centers
- The University of Alabama at Birmingham — Birmingham
- Stanford Hospital & Clinics — Stanford
- COR Healthcare — Torrance
- Childrens Hospital Colorado — Aurora
- Hartford Hosptial — Hartford
- Childrens National Medical Center — Washington D.C.
- Heart Rhythm Solutions — Hollywood
- Cardiovascular Institute of Northwest Florida — Panama City
- … and 44 more centers
France · 8 centers
- CHRU de Tours - Hôpital Trousseau — Chambray-lès-Tours
- Centre Hospitalier Universitaire de Grenoble - Site Nord — La Tronche
- Centre Hospitalier Régional Universitaire de Lille — Lille
- OC Santé - Clinique du Millénaire — Montpellier
- Hôpital Haut-Lévêque - CHU de Bordeaux — Pessac
- CHU de Rennes - Hôpital Pontchaillou — Rennes
- CHU Hôpitaux de Rouen - Hôpital Charles Nicolle — Rouen
- Clinique Pasteur — Toulouse
Spain · 5 centers
- Hospital Universitario Virgen de las Nieves — Granada
- Hospital Universitario da Coruña — A Coruña
- Hospital Universitario 12 de Octubre — Madrid
- Hospital Universitario Nuestra Señora de Candelaria — Santa Cruz de Tenerife
- Hospital Universitario y Politécnico La Fe — Valencia
Germany · 3 centers
- Klinikum Bielefeld — Bielefeld
- Saint Vinzenz Hospital Köln — Cologne
- Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum — Meerbusch
United Kingdom · 3 centers
- Liverpool Heart and Chest Hospital NHS Foundation Trust — Liverpool
- Imperial College Healthcare NHS Trust - Hammersmith Hospital — London
- Southampton General Hospital - University Hospital Southampton NHS Foundation Trust — Southampton
Austria · 1 center
- Kepler Universitätsklinikum Med Campus III — Linz
Canada · 1 center
- Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) — Québec
Identifiers
NCT: NCT07005232 · LEADR PAS