RESUMEN
AIMS: Pulsed field ablation (PFA) has emerged as a promising alternative to thermal ablation for treatment of atrial fibrillation (AF). We report performance and safety using the CENTAURI™ System (Galvanize Therapeutics) with three commercial, focal ablation catheters. METHODS AND RESULTS: ECLIPSE AF (NCT04523545) was a prospective, single-arm, multi-centre study evaluating safety and acute and chronic pulmonary vein isolation (PVI) durability using the CENTAURI System in conjunction with the TactiCath SE, StablePoint, and ThermoCool ST ablation catheters. Patients with paroxysmal or persistent AF were treated at two centres. Patients were analysed in five cohorts based upon ablation settings, catheter, and mapping system. Pulsed field ablation was performed in 82 patients (74% male, 42 paroxysmal AF). Pulmonary vein isolation was achieved in 100% of pulmonary veins (322/322) with first-pass isolation in 92.2% (297/322). There were four serious adverse events of interest (three vascular access complications and one lacunar stroke). Eighty patients (98%) underwent invasive remapping. Pulsed field ablation development Cohorts 1 and 2 showed a per-patient isolation rate of 38% and 26% and a per-PV isolation rate of 47% and 53%, respectively. Optimized PFA Cohorts 3-5 showed a per-patient isolation rate of 60%, 73%, and 81% and a per-PV isolation rate of 84%, 90%, and 92%, respectively. CONCLUSION: ECLIPSE AF demonstrated that optimized PFA using the CENTAURI System with three commercial, contact force-sensing, solid-tip focal ablation catheters resulted in transmural lesion formation and high proportion of durable PVI with a favourable safety profile, thus providing a viable treatment option for AF that integrates with contemporary focal ablation workflows.