Arrhythmias & electrophysiology
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
Study context
- Population
- Patients with drug-resistant paroxysmal atrial fibrillation (AF) undergoing pulmonary vein isolation (PVI)
- Participants
- 292 patients9 European centres5 countries
- Planned comparison
- Pulsed field ablation (PFA) vs radiofrequency (RF) ablation
- Primary endpoint
- Recurrence of atrial arrhythmia
- Follow-up
- 1 year
Methodological detailsmulticentre, superiority, open-label, two parallel groups, Major secondary safety endpoint: acute (<7 days) procedure-related serious adverse events, pulmonary vein stenosis or atrio-oesophageal fistula up to 12 months, Five sub-studies: oesophageal safety, cerebral lesions, cardiac autonomic nervous system, PVI durability at redo ablation, atrial and ventricular function, Study began 27 December 2021; recruitment concluded 17 January 2024; results expected mid-2025
- Multicentre
- Superiority
- Open-label
- Two parallel groups
- Major secondary safety endpoint: acute (<7 days) procedure-related serious adverse events, pulmonary vein stenosis or atrio-oesophageal fistula up to 12 months
- Five sub-studies: oesophageal safety, cerebral lesions, cardiac autonomic nervous system, PVI durability at redo ablation, atrial and ventricular function
- Study began 27 December 2021; recruitment concluded 17 January 2024; results expected mid-2025
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
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. Published 22 April 2024. doi:10.
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