- Question
- In patients with drug-resistant paroxysmal atrial fibrillation, is pulsed field ablation superior to point-by-point radiofrequency ablation in single-procedure efficacy?
- Design
- European, multicentre, open-label, randomized (1:1) superiority trial conducted at nine sites. A total of 292 patients were randomized and 289 were analysed (145 pulsed field, 144 radiofrequency), enrolled between December 2021 and January 2024.
- Population
- Adults aged 18-80 years with symptomatic, drug-resistant paroxysmal atrial fibrillation. Median age was 63.5 years and 58% were male.
- Intervention
- Pulsed field ablation using a pentaspline single-shot catheter.
- Control
- Point-by-point radiofrequency ablation following the CLOSE protocol, using a contact force sensing catheter and an electro-anatomical mapping system.
- Primary outcome
- Single-procedure success at 12 months, defined as absence of atrial arrhythmia recurrence ≥30 s, cardioversion, class I/III antiarrhythmic drug resumption after a 2-month blanking period, or any repeat ablation.
- Results
- Success at 12 months was 112/145 (77.2%) with pulsed field vs 111/143 (77.6%) with radiofrequency (adjusted difference 0.9%; 95% CI -8.2% to 10.1%; P = .84), with no significant difference.
- Safety
- Procedure-related serious adverse events occurred in 5 patients (3.4%) with pulsed field vs 11 (7.6%) with radiofrequency (difference -3.3%; 95% CI -8.4% to 1.8%). There were no deaths, persistent phrenic palsy or stroke. In the radiofrequency group, two patients had pulmonary vein stenosis >70% and 12 had >50%, two had tamponade and one had an oesophageal bleed.
- Conclusion
- Pulsed field ablation did not show superiority over CLOSE-protocol radiofrequency ablation for single-procedure freedom from atrial arrhythmias, although fewer safety events were observed with it.
- Why it matters
- It suggests that in paroxysmal atrial fibrillation, pulsed field ablation offers efficacy comparable to well-optimized radiofrequency, with a possible safety advantage, supporting its role as an alternative rather than an efficacy improvement.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 18, 2026