Arrhythmias & electrophysiology
Left bundle branch area stylet-driven lead: Performance, safety, and quality of life at 12 months after implant (the BIO-CONDUCT investigational device exemption study)
- multicenter, prospective, nonrandomized trial
Authors' conclusion
These 12-month results using the Solia S stylet-driven lead demonstrate freedom from LBBA pacing lead-related complications, acceptable lead performance characteristics, and a significant coincident improvement in a patient's physical function.
Study context
- Population
- Patients with standard pacing indications in whom a Solia S lead was implanted in the left bundle branch area (LBBA)patients who experienced a serious adverse device effect (SADE) event or had at least 335 days of follow-up
- Participants
- 161 patients
Main finding
As reported in the abstract
Pacing threshold · 12 months
Mean threshold at 0.4 ms
0.98 V
Mean threshold at implant
0.84 V
Observational data: associations, not effects.
Further findings
Sensing · 12 months
- Mean sensing
- 12.76 mV
- Mean sensing at implant
- 9.15 mV
Lead impedance · 12 months
- Mean impedance
- 521.8 Ω
- Mean impedance at implant
- 670.5 Ω
Quality of life (QOL) physical function scale · 12 months
- Mean change
- +11.4 ± 24.0
- 95% confidence interval
- 7.4-15.4
- t value
- 4.23
- P
- P < 0.001
Safety
Serious adverse device effect (SADE) · 12 months
- SADE-free rate (95% confidence interval 94.7-99.6)
- 98.1%
- SADE-free rate 0.02 events per subject-year (98.1%; 95% CI, 94.7-99.6)
- 161 patients who experienced a SADE event or had at least 335 days of follow-up
Original publication
Left bundle branch area stylet-driven lead: Performance, safety, and quality of life at 12 months after implant (the BIO-CONDUCT investigational device exemption study). Heart Rhythm. Published 19 March 2026. doi:10.1016/j.hrthm.2026.03.1889
Summarised from the published abstract; every number is checked against it