Although catheter ablation is widely used for symptomatic atrial fibrillation (AF), most prior trials have not included sham controls. A sham-controlled randomized trial published in Circulation evaluated the efficacy of pulsed field ablation (PFA) in patients with highly symptomatic AF.

The single-blind trial enrolled patients with symptomatic AF and poor baseline quality of life, defined by an Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score below 50. Participants were randomized 1:1 to undergo PFA or a sham procedure. All patients received implantable cardiac monitors for continuous rhythm monitoring during follow-up.

The co-primary endpoints at 6 months were time to first recurrence of atrial tachyarrhythmia and change in AFEQT score from baseline. Secondary outcomes included AF burden and psychological distress assessed using the Hospital Anxiety and Depression Scale (HADS).

Findings

• A total of 60 patients were randomized to PFA or sham treatment.
• At 6 months, atrial tachyarrhythmia recurrence occurred in 6.7% of patients treated with PFA and 83.3% of patients undergoing sham treatment (posterior hazard ratio 19.6; 95% Bayesian credible interval [CrI], 6.7-76.9).
• AFEQT scores improved by 43.9 ± 18.1 points with PFA compared with 11.3 ± 27.9 points with sham treatment (median difference 32.6 points; 95% CrI, 20.2-44.9).
• AF burden at 6 months was lower in the PFA group than in the sham group (0 [0-0] vs. 0.43 [0.04-3.47]; median difference −0.39; 95% CrI, −2.5 to −0.1).
• HADS scores decreased by 4 points with PFA and by 0.5 points with sham treatment (median difference −3.5; 95% CrI, −6.0 to −1.0).
• Posterior probability of superiority exceeded 99% for all primary and major secondary efficacy outcomes.

PFA was superior to a sham procedure in reducing AF recurrence and AF burden while improving quality of life and AF-related psychological distress.