Tachyarrhythmia
Conditions
Brief 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).
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
DEVICEdefibrillation 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.
Sponsors
Medtronic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication Survival Rate | 5 years | Estimate OmniaSecure lead-related complication-free survival through 5 years post implant. |
Countries
Austria, Canada, France, Germany, Spain, United Kingdom, United States
Outcome results
None listed