Arrhythmias & electrophysiologyResearch article
Pulsed-Field Ablation to Enhance the Durability of Pulmonary Vein Isolation and Treat Paroxysmal Atrial Fibrillation
- Single-arm trial
- multicentre
- pivotal investigational device exemption trial
Authors' conclusion
The favorable clinical success observed in this multicenter Food and Drug Administration trial of this novel PFA catheter appears to reflect the clinical success achievable with durable PVI in PAF patients.
Study context
- Population
- Patients with symptomatic drug-resistant or intolerant paroxysmal AF19 roll-in, 164 pivotal
- Participants
- 183 patients
- Outcome
- Freedom from atrial arrhythmias and from other failure modes (failure to achieve PVI, repeat ablation or cardioversion, new or increased class I/III antiarrhythmic drugs)
- Follow-up
- 12 months
Main finding
As reported in the abstract
Primary effectiveness (freedom from atrial arrhythmias and other failure modes)
Primary effectiveness at 12 months
77.8% (95% CI: 70.6%-83.9%)
Further findings
Pulmonary veins (PVs) isolated by first pulsed field application
- PVs electrically isolated by first application
- 94%, 607/647 veins
Durable PV isolation at redo ablation (11 patients)
- PVs durably isolated at redo ablation
- 39 of 41 (95.1%)
Procedure times
- Mapping time, min
- 9.0 ± 5.5
- Transpired ablation time, min
- 25.6 ± 9.8
- Left atrial catheter dwell time, min
- 59.9 ± 11.6
- Procedure time, min
- 95.8 ± 20.7
Safety
Primary safety events within 7 days
- Primary safety event rate (hemorrhagic stroke)
- 0.6% (1/164)
PV stenosis (substudy)
- Moderate or severe PV narrowing
- 0
Original publication
Pulsed-Field Ablation to Enhance the Durability of Pulmonary Vein Isolation and Treat Paroxysmal Atrial Fibrillation. J Am Coll Cardiol. Published 21 January 2026. doi:10.1016/j.jacc.2025.10.084
Summarised from the published abstract; every number is checked against it