Why the study?
All but one previous study comparing PVI to antiarrhythmic drugs was unblinded, raising the possibility of a placebo effect of catheter ablation.
Does pulmonary vein isolation using pulsed field energy reduce arrhythmia recurrence and improve quality of life compared to a sham procedure in symptomatic patients with atrial fibrillation?
Does pulmonary vein isolation using pulsed field energy reduce arrhythmia recurrence and improve quality of life compared to a sham procedure in symptomatic patients with atrial fibrillation?
The PFA-SHAM trial is an ongoing single-blind randomized study designed to evaluate the true efficacy of pulsed field ablation versus a sham procedure for symptomatic atrial fibrillation.
Will provide first sham-controlled efficacy data for PFA in AF; extends evidence beyond open-label trials.
Background: Compared with antiarrhythmic drugs, pulmonary vein isolation (PVI) reduces atrial fibrillation (AF) recurrences and AF burden. All but one previous study was unblinded, raising the possibility of a placebo effect of catheter ablation. Objective: This study aimed to compare PVI using pulsed field (PF) energy to a sham procedure in patients with symptomatic AF. Methods: PFA-SHAM is a single-blind, randomized trial of symptomatic patients with paroxysmal or persistent AF, and an Atrial Fibrillation Effect On Quality-of-Life (AFEQT) questionnaire score ≤50. At enrollment, all patients receive an implantable cardiac monitor, and an electrophysiology study is scheduled 30 days later. After excluding supraventricular tachycardia as a cause of AF, patients are randomized to either sham or PVI using the pentaspline PF ablation catheter. The 2 co-primary outcomes are (1) freedom from recurrent AF, atrial tachycardia, or atrial flutter lasting >30 seconds, assessed as time to first recurrence (post 2-month blanking); and (2) change in quality of life according to the AFEQT score at 6-month post-ablation, compared between groups. Cross-over is permitted for patients with significant symptom worsening according to pre-specified rules. Key secondary outcomes include AF burden at 6 months, and differences in the Hospital Anxiety and Depression Scale, compared between groups. Results: Enrollment in the study was initiated in September 2023. As of January 2025, 50 patients have been enrolled. Results are expected by the end of 2025. Conclusion: This study compares PVI using PF energy to a sham procedure. The study will assess the effect of PVI on AF recurrences and quality of life. Trial registration number: NCT02426944.
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Osmančík et al. (2025) studied this question.
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