Early Safety Profile Using Pulsed Field Ablation: Prospective Multicenter DISRUPT-AF Study.

Document Type

Article

Publication Title

JACC. Clinical electrophysiology

Abstract

BACKGROUND: Pentaspline pulsed field ablation (PFA) is an emerging technology delivering ultra-short bursts of ablative high electrical field energy. There are limited studies on atrial fibrillation (AF) ablation safety using PFA in real-world experience in the United States.

OBJECTIVES: The study sought to evaluate safety in patients who underwent AF ablation with a pentaspline PFA catheter in a multicenter registry.

METHODS: Patients from the prospective, multicenter, nonrandomized, rigorously monitored, real-world DISRUPT-AF (A registry Based Collaborative To Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF) registry (NCT06335082), who underwent first-time AF ablation via PFA using the pentaspline catheter, from April 2024 to May 2025, across 20 centers in the United States, encompassing 77 operators, were included. Baseline characteristics and acute procedural safety outcomes were collected at 1- and 3-month follow-up based on the investigator's arm: acute, symptomatic monitoring only, or full monitoring. The primary safety outcome comprised procedure/device-related adverse events (AEs) after 1 and 3 months. Risk-adjusted analyses were conducted to assess AE predictors.

RESULTS: A total of 1,576 patients were included: the mean age was 68.0 ± 11.4 years, 38.6% were female, and mean body mass index was 31.5 ± 7.0 kg/m

CONCLUSIONS: In this multicenter, prospective U.S. registry, PFA demonstrated a low rate of procedure/device-related AEs. The absence of injury to the esophagus, phrenic nerve, and pulmonary veins highlights a tissue-selective profile that may represent a meaningful safety advantage over traditional thermal ablation, pending further direct comparisons.

DOI

10.1016/j.jacep.2026.04.032

Publication Date

6-23-2026

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