Arrhythmias & electrophysiologyCohort study
Real-world experience with the pentaspline pulsed field ablation system: one-year outcomes of the FARADISE registry
- Prospective registry
- non-randomized
- multi-national
- 48 centres in 21 countries
Authors' conclusion
Acute results demonstrate favourable procedural and safety outcomes regardless of AF indication. One-year outcomes are encouraging, with no differences seen within indication based on ablation strategy.
Study context
- Population
- Atrial fibrillation (AF) patients clinically indicated for ablation with the pentaspline PFA catheter in real-world practice
- Participants
- 1,158 participants · 48 centres · 21 countries
- Exposure
- Pulmonary vein isolation (PVI)-only vs PVI+ lesion set, by AF indication
- Outcome
- Clinical effectiveness
- Follow-up
- 1 year
Main finding
As reported in the abstract
Clinical effectiveness · 1 year
PVI-only
PVI+
- PVI-only vs PVI+: P = 0.65 — paroxysmal AF
- PVI-only vs PVI+: P = 0.79 — non-paroxysmal AF
Observational data: associations, not effects.
Further findings
PVI-only procedures, by AF indication
P < 0.01
Procedural times (all patients)
- Median procedure time, min
- 51[40-70]
- Median left atrial dwell time, min
- 31[24-41]
- Median fluoroscopy time, min
- 12[8-17]
1-year effectiveness by operator experience
- Short procedural learning curve; no difference in 1-year effectiveness by operator experience
Safety
Early onset serious adverse events
- Rate (all patients); did not differ by ablation strategy or AF indication
- 1.5%
Original publication
Real-world experience with the pentaspline pulsed field ablation system: one-year outcomes of the FARADISE registry. Europace. Published 1 September 2025. doi:10.1093/europace/euaf182
Summarised from the published abstract; every number is checked against it