Arrhythmias & electrophysiologyResearch article
LEAP2: A first-in-human evaluation of a chronically implanted novel leadless pacemaker for conduction system pacing
- first-in-human evaluation
Authors' conclusion
This first-in-human evaluation demonstrated the feasibility of leadless CSP, but improvements in LPCSP stability fixation require further evaluation.
Study context
- Population
- Pacemaker-indicated patientsenrolled, 1 withdrawn for challenging anatomy
- Participants
- 20 patients
- Comparison
- ventricular-only vs dual-chamber
- ventricular-onlyn = 4
- dual-chambern = 14
- Outcome
- Complications
- Follow-up
- 1-month
Main finding
As reported in the abstract
1-month LPCSP complication-free-rate
73.7%
patients experienced complications, including internal jugular-access hematoma, LPCSP dislodgements, and dislocation
5
Further findings
LPCSP implantation success
- Successful implantation
- 18 of 19 patients
Electrical performance · 1 month
- capture threshold
- 1.3 ± 0.6 V
- R-wave amplitude
- 13.1 ± 4.0 mV
- impedance
- 490 ± 72 Ω
- acceptable at implant
Capture type · implant
- LBBP
- 9
- LVSP
- 5
- DSP
- 4
- capture type changed by 1-month follow-up
- 6 patients
Implant-to-implant communication (dual-chamber) · 1-month
- stable through 1-month
Safety
Dislodgements
- patients had dislodgements
- 3
Original publication
LEAP2: A first-in-human evaluation of a chronically implanted novel leadless pacemaker for conduction system pacing. Heart Rhythm. Published 25 April 2026. doi:10.1016/j.hrthm.2026.04.014
Summarised from the published abstract; every number is checked against it