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BEAT-PAROX-AF: Pulsed Field Ablation Not Superior to Radiofrequency Ablation in AF

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Despite an excellent safety and tolerability profile and proven efficacy in treating atrial fibrillation, PFA failed to prove superiority to RA.

Pulsed field ablation (PFA) does not have superior efficacy to radiofrequency ablation (RFA) in treating drug-resistant paroxysmal atrial fibrillation (AF), according to the late-breaking BEAT-PAROX-AF trial presented at the European Society of Cardiology Congress 2025.1

Thermal ablation is considered effective and reasonably safe in patients with symptomatic paroxysmal AF, but treatment success is relatively limited, with single-procedure success rates routinely hovering between 60% and 80%. Thermal ablation can also cause rare but significant complications, since they cannot ablate specific types of tissue selectively. The main factor is widely considered to be pulmonary vein reconnection, which has led to increased research into creating more durable lesions when performing catheter ablation.2

PFA is a novel, non-thermal strategy based on pulsed electric field energy delivery, which allows highly selective ablation resulting in safe, durable, and transmural lesions. Smaller studies have indicated the safety and efficacy of this method, although there is little literature comparing PFA to standard RF ablation.2

“We hypothesize that PEF energy, a non-thermal ablative modality highly specific for cardiac cells, will deliver more durable PVI and RF energy, translating into superior clinical outcomes for PFA as compared with RF energy,” Nico Erhard, MD, department of electrophysiology, German Heart Center Munich, and colleagues wrote. “By evaluating the outcomes of PFA, the study aims to provide critical insights into the optimal treatment approach for paroxysmal AF, to improve their clinical outcomes, including quality of life, and procedural duration.”2

BEAT-PAROX-AF was an open-label, randomized, controlled superiority trial, which was conducted at nine centers across France, Germany, Austria, Czechia, and Belgium. Eligible patients were aged 18 to 80 years and had symptomatic paroxysmal AF resistant to ≥1 antiarrhythmic drug. Patients also had to have a Class I or IIa indication for AF ablation, according to ESC guidelines and effective oral anticoagulation for >3 weeks prior to the trial.1

Investigators randomly assigned patients in a 1:1 ratio to pulmonary vein isolation using either single-shot PFA or point-by-point RFA following the CLOSE protocol. The team then instructed patients to perform weekly self-recorded single-lead ECGs and to capture recordings during symptomatic episodes using a mobile ECG system for follow-up. Investigators noted the primary endpoint as the single-procedure success rate after 12 months, which they defined as the absence of ≥30-second atrial arrhythmia recurrence, cardioversion, Class I/III antiarrhythmic drug resumption after a 2-month blanking period, or any repeat ablation.1

A total of 289 patients were included in the study. The mean age was 63.5 years, and 42% were female. The mean duration of drug-resistant AF was 39 months. The primary endpoint was high and similar between both procedure types, with 77.2% in the PFA group and 77.6% in the RFA group and an adjusted difference of 0.9% (95% CI, -8.2 to 10.1; P = .84). Mean total procedure duration was significantly shorter for PFA (56 versus 95 minutes), with an adjusted difference of -39 minutes (95% CI, -44 to -34).1

Both groups exhibited a good safety profile, with procedure-related serious adverse events occurring in 5 patients (3.4%) in the PFA group and 11 (7.6%) in the RFA group. Complications were more frequent with RFA, including 2 tamponades percutaneously drained and 2 cases of pulmonary vein stenosis >70%. Pulmonary vein stenosis occurred in 12 patients and 15 patients, respectively.1

“Both PFA and RFA using the CLOSE protocol showed excellent and similar efficacy,” Pierre Jaïs, MD, professor at the Cardiology Hospital, Pessac, France, and a principal investigator in BEAT-PAROX-AF said in a press release from the ESC Congress. “Single-procedure success rates were comparable, although there appeared to be fewer complications and a shorter procedure time with PFA.”1

References
  1. European Society of Cardiology. Pulsed field ablation was not superior to radiofrequency ablation in paroxysmal atrial fibrillation. August 31, 2025. Accessed September 2, 2025. https://www.escardio.org/The-ESC/Press-Office/Press-releases/Pulsed-field-ablation-was-not-superior-to-radiofrequency-ablation-in-paroxysmal-atrial-fibrillation#
  2. Erhard N, Frison E, Asselineau J, et al. Comparing pulsed field electroporation and radiofrequency ablation for the treatment of paroxysmal atrial fibrillation: design and rationale of the BEAT PAROX-AF randomized clinical trial. Europace. 2024;26(5):euae103. doi:10.1093/europace/euae103

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