First-in-Human Clinical Series of a Novel Conformable Large-Lattice Pulsed Field Ablation Catheter for Pulmonary Vein Isolation

Abstract

Background/Aims Pulsed field ablation (PFA) has significant advantages over conventional thermal ablation of atrial fibrillation (AF). This first-in-human, single-arm trial to treat paroxysmal AF (PAF) assessed the efficiency, safety, pulmonary vein isolation (PVI) durability and one-year clinical effectiveness of an 8-Fr, large-lattice, conformable single-shot PFA catheter together with a dedicated electroanatomical mapping system. Methods After rendering the PV anatomy, the PFA catheter delivered monopolar, biphasic pulse trains (5-6 secs per application; ∼4 applications per PV). Three waveforms were tested: PULSE1, PULSE2 and PULSE3. Follow-up included ECGs, Holters at 6 and 12 months, and symptomatic and scheduled transtelephonic monitoring. The primary and secondary efficacy endpoints were acute PVI and post-blanking atrial arrhythmia recurrence, respectively. Invasive remapping was conducted ∼75 days post-ablation. Results At three centers, PVI was performed by five operators in 85 patients using PULSE1 (n=30), PULSE2 (n=20), and PULSE3 (n=35). Acute PVI was achieved in 100% of PVs using 3.9±1.4 PFA applications per PV. Overall procedure, transpired ablation, PFA catheter dwell and fluoroscopy times were 56.5±21.6, 10.0 ± 6.0, 19.1±9.3 and 5.7±3.9 min, respectively. No pre-defined primary safety events occurred. Upon remapping, PVI durability was 90% and 99% on a per vein basis for the total and PULSE3 cohort, respectively. The Kaplan-Meier estimate of one-year freedom from atrial arrhythmias was 81.8% (95% CI 70.2-89.2%) for the total, and 100% (95% CI 80.6-100%) for the PULSE3 cohort. Conclusion PVI utilizing a conformable single-shot PFA catheter to treat PAF was efficient, safe, and effective, with durable lesions demonstrated upon remapping.