12-month outcomes of pulsed-field ablation with a variable-diameter circular catheter for paroxysmal atrial fibrillation: Insights into conscious sedation and fluoroscopy use.

Background: Pulsed-field ablation (PFA) emerges as an innovative nonthermal energy modality for catheter ablation of atrial fibrillation (AF). This study aimed to assess the safety and effectiveness of a novel PFA system that uses a multichannel, circular ablation catheter with adjustable diameters in treating paroxysmal AF.

Methods: This clinical trial (PF-Beat-AF) was a prospective, multicenter, single-arm study. Patients with paroxysmal AF underwent pulmonary vein isolation (PVI) using the PFA system, and were followed at discharge, 7-day, 1-, 3-, 6- and 12-month post-procedure. Primary safety endpoint was the incidence of primary adverse events (PAEs). While primary effectiveness endpoint was freedom from documented atrial arrhythmia recurrence lasting >30 s during the 3-12 months evaluation period.

Results: A total of 161 patients were enrolled and 159 patients were treated in eight centers. Conscious sedation was used in 68.6 % of cases, and 40.9 % of procedures were completed without fluoroscopy. The mean total procedure time was 132.3 ± 40.4 min, and fluoroscopy time averaged 6.4 ± 6.8 min. Acute PVI was achieved in 100 % of patients. One PAE (0.6 %) occurred (pericardial tamponade, resolved). At 12 months, 87.7 % (95 % CI: 82.5 %-92.9 %) of patients remained free from atrial arrhythmia after the blanking period. No significant differences in effectiveness were observed between conscious sedation and general anesthesia/deep sedation, or fluoroscopy and zero-fluoroscopy cases.

Conclusion: The results of clinical trial demonstrated the safety and effectiveness of the PFA system in treating paroxysmal AF, including successful use with conscious sedation and zero-fluoroscopy.