Update on first-in-human experience of high-energy ElectroPulse pulsed field ablation

The ElectroPulse system is a novel pulsed field ablation (PFA) platform integrating mapping and ablation in a small-diameter catheter with irrigation and wire-free design.

The purpose of this study was to present mid-term outcomes from 2 sequential first-in-human cohorts for pulmonary vein isolation and posterior wall isolation (PVI and PWI).

The ElectroPulse trial enrolled 60 patients with symptomatic atrial fibrillation undergoing de novo ablation. Cohort 1 (n = 30) followed the standard protocol, while cohort 2 (n = 30) used a modified protocol. The primary end point was time to first atrial arrhythmia ≥30 seconds; secondary end points included efficacy and safety, with exploratory analyses of pulmonary vein reconnection and lesion durability. Outcomes were assessed through clinic visits, electrocardiograms, and 4-day Holter monitoring every 3 months.

Compared with patients in cohort 1, those in cohort 2 were older (P = .005), had larger left atrial volumes (P = .009), and higher CHA₂DS₂-VA scores (P = .002). The modified protocol reduced PFA applications and procedure time (P < .001), with 100% (n = 60) acute PVI/PWI in both cohorts. At 6 months, 16% (n = 5) of cohort 1 and 13% (n = 4) of cohort 2 had atrial fibrillation recurrence (P = .834). Redo ablation was required in 16.6% (n = 5) of cohort 1 but only in 3.3% (n = 1) of cohort 2 (P = .19). Durable PVI was seen in 27% (n = 3) of repeat procedures in cohort 1 vs 100% (n = 3) in cohort 2. Complication rates were low and similar.

ElectroPulse PFA enables safe and effective PVI and PWI. The updated high-energy protocol improves efficiency by reducing applications and procedure duration while increasing durability without compromising safety or efficacy.