Arrhythmias & electrophysiology
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
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
Methodological detailsglobal
- Global
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.
Summarised from the published abstract; every number is checked against it