Arrhythmias & electrophysiologyResearch article
Safety and performance of a novel defibrillation lead for left bundle branch area placement: Primary results of the LEADR left bundle branch area pacing (LBBAP) clinical trial
- clinical trial
- global
Authors' conclusion
These results demonstrate that implantation of OmniaSecure lead when intended for LBBAP results in high defibrillation success at implant, stable short-term electrical parameters, and a low rate of OmniaSecure lead-related major complications at 3 months.
Study context
- Population
- Patients indicated for de novo implantation of a primary or secondary prevention implantable cardioverter-defibrillator or cardiac resynchronization therapy with a defibrillator, with the OmniaSecure defibrillation lead intended for left bundle branch area pacing (LBBAP)patients who underwent an LBBAP implant attempt, 293 successfully implanted per protocol (95.4%)
- Participants
- 307 patients
- Outcome
- Defibrillation efficacy at implant (primary efficacy objective; prespecified threshold of 88% in ≥160 patients)
- Follow-up
- At implant
Main finding
As reported in the abstract
OmniaSecure lead for LBBAP
100%
- Primary efficacy objective met; patients defibrillated to protocol
- 100%
Further findings
Implant success per protocol
- Patients successfully implanted per protocol
- 293 (95.4%)
Electrical parameters · 2.6 ± 2.5 months' follow-up
- Stable electrical parameters
Safety
| Outcome | Values |
|---|---|
| Freedom from OmniaSecure lead-related major complications (primary safety endpoint) · 3 months · primary safety endpoint | OmniaSecure lead for LBBAP 97.9% (95% CI 95.8–100) |
Study lead fractures and oversensing adverse events · 2.6 ± 2.5 months' follow-up
- Study lead fractures
- zero
- No oversensing adverse events
Original publication
Safety and performance of a novel defibrillation lead for left bundle branch area placement: Primary results of the LEADR LBBAP clinical trial. Heart Rhythm. Published 17 October 2025. doi:10.1016/j.hrthm.2025.10.028
Summarised from the published abstract; every number is checked against it