Results of the Pulsed AF Pivotal trial, investigating pulsed field ablation (PFA) treatment in patients with paroxysmal and persistent atrial fibrillation (AF), have been shared at the American College of Cardiology (ACC) 2023 Scientific Sessions (4 – 6 March, New Orleans, USA), and have demonstrated “promising” safety and efficacy results, according to investigators.
Atul Verma (McGill University Health Centre, Montreal, Canada) presented acute and long term outcomes from the trial, which involved the Medtronic PulseSelect PFA system, reporting that the study exceeded its performance goal of freedom from a composite of serious procedure and device-related adverse events with a 0.7% (p=0.002) rate of primary adverse events in both patient cohorts.
Furthermore, the study exceeded the threshold for efficacy performance at 66% efficacy in paroxysmal AF patients and 55% in persistent AF patients (p<0.001), based on the pre-specified performance goals of >50% (paroxysmal) and >40% (persistent) at 12 months.
PULSED AF is designed to evaluate the safety and efficacy of the PulseSelect System for the treatment of AF in adult patients with a history of drug refractory, recurrent and symptomatic paroxysmal or persistent AF.
The trial is a prospective, single arm, multicentre clinical trial that treated 300 patients (150 with paroxysmal AF and 150 with persistent AF). Patients were enrolled across 41 sites in nine countries with 67 operators throughout the USA, Canada, Europe, Australia, and Japan. Alongside the presentation at ACC, the findings were simultaneously published in Circulation.
The PULSED AF primary effectiveness endpoint included a composite of measures based on efficacy endpoints across multiple studies of radiofrequency (RF) and cryoablation energy sources. The composite endpoint included freedom from acute procedural failure, arrhythmia recurrence, repeat ablation, direct current cardioversion, left atrial surgery, or antiarrhythmic escalation through twelve months, excluding a 3-month blanking period.
Freedom from atrial arrhythmia recurrence at 12 months was 70% in the paroxysmal cohort and 62% in the persistent. Additionally, clinical success, freedom from recurrence of any symptomatic atrial arrhythmias, was 80% for paroxysmal and 81% for the persistent cohort.
“Uniquely, these results represent the first prospective, global, large-scale study with two different, rigorously monitored patient populations that demonstrates an impressively low adverse event rate of 0.7%,” said Verma, the principal investigator for the study. “The results of PFA trials have been highly anticipated among the electrophysiology community to help us treat the growing number of AF patients around the world. The high rate of 80% or more in clinical success and the promising safety and efficiency results from PULSED AF will help establish PFA as an exciting new option for patients.”