Key result
Pulsed field ablation did not demonstrate superior efficacy compared to radiofrequency ablation for single-procedure freedom from atrial arrhythmias at 12 months (77.2% vs 77.6%; P=0.84).
Why the study?
Does pulsed field ablation improve single-procedure success compared to radiofrequency ablation in patients with symptomatic, drug-resistant paroxysmal atrial fibrillation?
RCT (n=289)
Open-label
1:1
Yes
Does pulsed field ablation improve single-procedure success compared to radiofrequency ablation in patients with symptomatic, drug-resistant paroxysmal atrial fibrillation?
Pulsed field ablation did not demonstrate superior efficacy to radiofrequency ablation for single-procedure freedom from atrial arrhythmias in paroxysmal AF, though it was associated with fewer safety events.
Answers are grounded in this paper and cite their sources.
Single-shot PFA was not superior to point-by-point RFA for arrhythmia freedom in paroxysmal AF; challenges assumptions of PFA superiority and reinforces RFA as the efficacy benchmark.
BACKGROUND AND AIMS: This trial compared single-procedure efficacy and safety of pulsed field ablation (PFA) vs radiofrequency ablation (RFA) in patients with drug-resistant paroxysmal atrial fibrillation (AF). METHODS: BEAT PAROX-AF is a European, multicentre, open-label, randomized, controlled, superiority trial conducted across nine European sites. Eligible patients (aged 18-80 years) with symptomatic, drug-resistant paroxysmal AF were randomized (1:1) to either PFA (pentaspline) or RFA following the CLOSE protocol (contact force sensing catheter and electro-anatomical mapping system). The primary endpoint was the single-procedure success rate after 12 months defined as the absence of ≥30 s atrial arrhythmia recurrence, cardioversion, class I/III antiarrhythmic drug resumption after a 2-month blanking period, or any repeat ablation. RESULTS: From December 2021 to January 2024, 292 patients were randomized and 289 (median age 63.5 years, 58% male) were analysed (PFA n = 145, RFA n = 144). Single-procedure success at 12 months was 112/145 (77.2%) in the PFA group and 111/143 (77.6%) in the RFA group (adjusted difference 0.9%; 95% confidence interval -8.2% to 10.1%; P = .84). Procedure-related serious adverse events occurred in 5 (3.4%) PFA vs 11 (7.6%) RFA patients (difference -3.3% [-8.4%, 1.8%]). No deaths, persistent phrenic palsy nor stroke occurred. In the RFA group, two patients had pulmonary vein stenosis >70% and 12 > 50%, two tamponades, and one oesophageal bleed. CONCLUSIONS: This randomized trial performed in patients with paroxysmal AF did not demonstrate superior efficacy of single-shot PFA vs point-by-point RFA using the CLOSE protocol regarding single-procedure freedom from atrial arrhythmias, despite fewer safety events being observed in this study with PFA.
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Jais et al. (2026) conducted an RCT in Paroxysmal atrial fibrillation (n=289). Pulsed field ablation (PFA) vs. Radiofrequency ablation (RFA) was evaluated on single-procedure success rate after 12 months defined as the absence of ≥30 s atrial arrhythmia recurrence, cardioversion, class I/III antiarrhythmic drug resumption after a 2-month blanking period, or any repeat ablation (adjusted difference 0.9%, 95% CI -8.2 to 10.1, p=0.84). Pulsed field ablation did not demonstrate superior efficacy compared to radiofrequency ablation for single-procedure freedom from atrial arrhythmias at 12 months (77.2% vs 77.6%; P=0.84).
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