Arrhythmias & electrophysiology
Safety, efficacy, and reliability evaluation of a novel small-diameter defibrillation lead: Global LEADR pivotal trial results
Authors' conclusion
The OmniaSecure lead exceeded prespecified primary end point performance goals for safety and efficacy, demonstrating high defibrillation success and a low occurrence of lead-related major complications with zero lead fractures.
Study context
- Population
- Patients indicated for de novo primary or secondary prevention ICD or CRT-D implantation505 completed 12-month follow-up
- Participants
- 643 patients
- Outcome
- Efficacy: successful defibrillation at implantation per protocol; safety: freedom from study lead-related major complications
- Follow-up
- 6 months (safety); at implantation (efficacy)
Methodological detailsworldwide
- Worldwide
Main finding
As reported in the abstract
Successful defibrillation at implantation (testing completed in 119 patients)
97.5%
Kaplan-Meier freedom from study lead-related major complications at 6 months
97.1%
Further findings
Lead placed in desired RV location
- Placed in desired RV location
- 99.5%
Freedom from study lead-related major complications (Kaplan-Meier) · 12 months
- Freedom from lead-related major complications at 12 months
- 97.1%
Lead fractures and electrical performance · mean follow-up 12.7 ± 4.8 months (mean ± SD)
- Study lead fractures
- 0
- Electrical performance stable throughout follow-up
Safety
| Outcome | Values |
|---|---|
| Study lead fractures · mean follow-up 12.7 months | OmniaSecure 0 events |
Study lead fractures · mean follow-up 12.7 months
- Electrical performance stable throughout follow-up
Original publication
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