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

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 occ...

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Published in:Europace (London, England) England), 2024-05, Vol.26 (5)
Main 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
Format: Article
Language:English
Subjects:
Atrial Fibrillation - diagnosis
Atrial Fibrillation - physiopathology
Atrial Fibrillation - surgery
Atrial Fibrillation - therapy
Catheter Ablation - methods
Europe
Female
Humans
Male
Middle Aged
Pulmonary Veins - surgery
Recurrence
Treatment Outcome
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Summary: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. 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 (
ISSN:1099-5129
1532-2092
DOI:10.1093/europace/euae103