Arrhythmias & electrophysiology
First-in-human clinical series of a novel conformable large-lattice pulsed field ablation catheter for pulmonary vein isolation
Authors' conclusion
Pulmonary vein isolation (PVI) utilizing a conformable single-shot PFA catheter to treat PAF was efficient, safe, and effective, with durable lesions demonstrated upon remapping.
Study context
- Population
- Patients with paroxysmal AF undergoing pulmonary vein isolation (PVI) with an 8 Fr large-lattice conformable single-shot pulsed field ablation (PFA) catheter
- Participants
- 85 patients
- Comparison
- PULSE1 vs PULSE2 vs PULSE3
- PULSE1n = 30
- PULSE2n = 20
- PULSE3n = 35
- Outcome
- Acute PVI
Methodological details3 centres, 5 operators
- 3 centres
- 5 operators
Main finding
As reported in the abstract
Acute PVI achieved (% of PVs)
100%
PFA applications per PV (mean ± SD)
3.9 ± 1.4
Secondary outcomes
- 1-year freedom from atrial arrhythmias (Kaplan-Meier) · one year — PULSE3
- 100% (95% CI 80.6–100%)
- PVI durability at remapping (per vein) · ∼75 days post-ablation — PULSE3
- 99%
- 1-year freedom from atrial arrhythmias (Kaplan-Meier) — Total cohort
- 81.8% (95% CI 70.2-89.2%)
- PVI durability at remapping (per vein) — Total cohort
- 90%
Procedure times (overall procedure, transpired ablation, PFA catheter dwell, fluoroscopy)
- Overall procedure time (min)
- 56.5 ± 21.6
- Transpired ablation time (min)
- 10.0 ± 6.0
- PFA catheter dwell time (min)
- 19.1 ± 9.3
- Fluoroscopy time (min)
- 5.7 ± 3.9
Safety
- No pre-defined primary safety events occurred
Original publication
First-in-human clinical series of a novel conformable large-lattice pulsed field ablation catheter for pulmonary vein isolation. Europace. Published 8 April 2024. doi:10.
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