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
Authors: Erhard Nico , Frison Eric , Asselineau Julien , Aouar Besma , Boveda Serge , Cochet Hubert , Deisenhofer Isabel , Deneke Thomas , Gimbert Anne , Kautzner Josef , Knecht Sebastien , Maury Philippe , Neuzil Petr , Rousset Marine , Scherr Daniel , Schneider Christopher W , Sermesant Maxime , Wichterle Dan , Jaïs Pierre ,   BEAT-AF Study group, Allison John , Aouar Besma , Aoudjit Tiziri , Asselineau Julien , Benkert Laura , Boveda Serge , Enzinger Christian , Cochet Hubert , Deisenhofer Isabel , Deneke Thomas , Frison Eric , Gimbert Anne , Jaïs Pierre , Kautzner Josef , Knecht Sebastien , Lycke Michelle , Maury Philippe , Mingam Rozenn , Neuzil Petr , Piquet Maider , Regueme Sophie , Roseng Stephanie , Rousset Marine , Scherr Daniel , Schneider Christopher , Schwimmer Christine , Sermesant Maxime , Wallet Cedrick , Wichterle Dan , Aouar Besma , Aoudjit Tiziri , Asselineau Julien , Frison Eric , De Muro Thomas Gil , Gimbert Anne , Jaïs Pierre , Merched Maria , Richert Laura , Rousset Marine , Schwimmer Christine , Wallet Cédrick , Jais Pierre , Scherr Daniel , Knecht Sebastien , Neuzil Petr , Deneke Thomas , Gimbert Anne , Rousset Marine , Frison Eric , Asselineau Julien , Cochet Hubert , Wichterle Dan , Lobban Trudie , Morgan John , Aouar Besma , De Muro Thomas Gil , Sermesant Maxime , Richert Laura , Schwimmer Christine , Wallet Cédrick , Alexander Andréa , Andriamandroso Christiane , Duflos Claire , Denis Arnaud , Guy-Moyat Benoît , Derval Nicolas , Sacher Frederic , Bouyer Benjamin , Cheniti Ghassen , HOCINI Meleze , Jaïs Pierre , Maury Philippe , Rollin Anne , Boveda Serge , Combes Stephane , Albenque Jean-Paul , Kautzner Josef , Haskova Jana , Peichl Petr , Stojadinovic Predrag , Wichterle Dan , Neuzil Petr , Hala Pavel , PETRU Jan , Deneke Thomas , Ene Elena , Nentwich Karin , Deisenhofer Isabel , Bourier Felix , Englert Florian , Erhard Nico , Hofmann Monika , Kottmaier Marc , Lengauer Sarah , Reents Tilko , Syvari Jan , Telishevska Marta , Martinez Alex Tunsch , Scherr Daniel , Benedikt Martin , Eberl Anna-Sophie , Manninger-Wuenscher Martin , Rohrer Ursula , Knecht Sebastien , Duytschaever Mattias , de Waroux Jean-Benoît Le Polain , Tavernier René , Deneke Thomas , Scherr Daniel , Enzinger Christian , Wichterle Dan , Knecht Sébastien , Cochet Hubert , Sermesant Maxime , Gurunathan Vigneshwar , Castelneau Julien 
Published: April 2024

Abstract

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 (&lt;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.