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.

中文翻译：

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用于肺静脉隔离的新型适形大格子脉冲场消融导管的首次人体临床系列

背景/目标 脉冲场消融 (PFA) 比心房颤动 (AF) 的传统热消融具有显着优势。这项治疗阵发性 AF (PAF) 的首次人体单臂试验评估了 8-Fr、大网格、适形单臂治疗的效率、安全性、肺静脉隔离 (PVI) 耐久性和一年临床有效性。将 PFA 导管与专用电解剖标测系统一起注射。方法 渲染 PV 解剖结构后，PFA 导管输送单极、双相脉冲序列（每次应用 5-6 秒；每个 PV 约 4 次应用）。测试了三个波形：PULSE1、PULSE2 和 PULSE3。随访包括心电图、6 个月和 12 个月时的动态心电图以及症状和预定的电话监测。主要和次要疗效终点分别是急性 PVI 和消隐后房性心律失常复发。消融后约 75 天进行侵入性重新映射。结果 在三个中心，五名操作员使用 PULSE1 (n=30)、PULSE2 (n=20) 和 PULSE3 (n=35) 对 85 名患者进行了 PVI。每个 PV 使用 3.9±1.4 PFA，100% 的 PV 实现了急性 PVI。整个过程、蒸发消融、PFA导管停留和透视时间分别为56.5±21.6、10.0±6.0、19.1±9.3和5.7±3.9分钟。没有发生预先定义的主要安全事件。重新映射后，总队列和 PULSE3 队列的每条静脉的 PVI 持久性分别为 90% 和 99%。 Kaplan-Meier 估计一年内无房性心律失常的概率为 81.8%（95% CI 70.2-89.2%），PULSE3 队列为 100%（95% CI 80.6-100%）。结论 PVI 利用顺应性单次 PFA 导管治疗 PAF 是高效、安全、有效的，重新标测后显示出持久的病变。