AIMS: Using thermal-based energy sources [radiofrequency (RF) energy/cryo energy] for catheter ablation is considered effective and safe when performing pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (AF). However, treatment success remains limited and complications can occur due to the propagation of thermal energy into non-target tissues. We aim to compare pulsed field ablation (PFA) with RF ablation in terms of efficacy and safety for patients with drug-resistant paroxysmal AF. METHODS AND RESULTS: The BEAT PAROX-AF trial is a European multicentre, superiority, open-label randomized clinical trial in two parallel groups. A total of 292 participants were recruited in 9 high-volume European clinical centres in 5 countries. Patients with paroxysmal AF were randomized to PFA (FARAPULSE Endocardial Ablation System©, Boston Scientific) or RF using the CLOSE protocol with contact force sensing catheter (SmartTouch© catheter and CARTO© Biosense Webster). The primary endpoint will be the 1-year recurrence of atrial arrhythmia, and the major secondary safety endpoint will be the occurrence of acute (<7 days) procedure-related serious adverse events, or pulmonary vein stenosis, or atrio-oesophageal fistula up to 12 months. Additionally, five sub-studies investigate the effect of PFA on oesophageal safety, cerebral lesions, cardiac autonomic nervous system, durability of PVI as assessed during redo ablation procedures, and atrial and ventricular function. The study began on 27 December 2021 and concluded recruitment on 17 January 2024. Results will be available in mid-2025. CONCLUSION: The BEAT PAROX-AF trial aims to provide critical insights into the optimal treatment approach for patients with paroxysmal AF.

Cardiology Department Na Homolce Hospital Homolka Hospital Prague Czechia

Clinical Research and Innovation Department CHU Bordeaux Bordeaux France

Department of Cardiology AZ Sint Jan Hospital Bruges Belgium

Department of Cardiology Cardiovascular Center Bad Neustadt Saale Bad Neustadt an der Saale Germany

Department of Cardiology Institute for Clinical and Experimental Medicine Prague Czechia

Department of Cardiology University Hospital Rangueil Toulouse France

Department of Electrophysiology Boston Scientific Corporation St Paul MN USA

Department of Electrophysiology German Heart Center Munich Lazarettstraße 36 80636 Munich Technical University of Munich Munich Germany

Division of Cardiology Medical University of Graz Graz Austria

Heart Rhythm Department Clinique Pasteur Toulouse France

IHU LIRYC University Bordeaux CHU Bordeaux Bordeaux France

IHU LIRYC University Bordeaux INSERM CRCTB U 1045 Bordeaux France

Inria Université Côte d'Azur Epione Team Sophia Antipolis France

University Bordeaux INSERM Institut Bergonié CHU Bordeaux CIC 1401 EUCLID F CRIN Clinical Trials Platform Bordeaux France

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