Pulsed field ablation was superior to sham in reducing atrial tachyarrhythmia recurrence at 6 months (6.7% vs 83.3%; posterior HR 19.6, 95% CrI 6.7-76.9; probability of superiority >0.99).
RCT (n=60)
Single-blind
1:1
Does pulsed field ablation reduce atrial tachyarrhythmia recurrence and improve quality of life compared to a sham procedure in patients with highly symptomatic atrial fibrillation?
Pulsed field ablation is superior to a sham procedure in reducing arrhythmia recurrences, decreasing AF burden, and improving quality of life in patients with highly symptomatic atrial fibrillation.
Effect estimate: posterior HR 19.6 (95% CI 6.7-76.9)
Absolute Event Rate: 6.7% vs 83.3%
p-value: p=>0.99 (posterior probability of superiority)
BACKGROUND: Catheter ablation for atrial fibrillation (AF) is one of the most common cardiovascular procedures being performed worldwide. Despite the large body of evidence of its effectiveness, with a single exception, prior ablation studies were largely unblinded trials. Accordingly, residual concerns remained about placebo effects, both for AF recurrence and, in particular, on subjective outcomes such as quality of life or anxiety. Here, we compared pulsed field ablation (PFA) with a sham procedure to treat patients with symptomatic AF. METHODS: This prospective, sham-controlled, single-blind, randomized clinical trial with blinded end-point assessment enrolled patients with AF that was highly symptomatic (Atrial Fibrillation Effect on Quality-of-Life score 0.99). For the second co-primary end point, Atrial Fibrillation Effect on Quality-of-Life scores showed greater improvement from baseline with PFA than sham (improved by 43.9+18.1 points versus 11.3+27.9 points; posterior median difference, 32.6 95% bayesian credible interval, 20.2-44.9; posterior probability of superiority >0.99). AF burden at 6 months was significantly lower in the PFA than the sham group (0 0-0 versus 0.43 0.04-3.47; between group median difference, -0.39 95% credible interval, -2.5 to -0.1, posterior probability of superiority >0.99). The Hospital Anxiety and Depression Scale score changed by -4 points (-7.8 to -2.0) with PFA and by -0.5 (-4.5 to 1.0) with sham (group median difference, -3.5 95% credible interval, -6.0 to -1.0; posterior probability of superiority >0.99). CONCLUSIONS: In patients with AF, PFA was superior to sham in reducing arrhythmia recurrences and burden and improving quality of life and AF-associated psychological distress.
“It provides strong evidence of efficacy of the active treatment and evidence against it just being a placebo effect. And it treats both the doctor and the patient. It treats us by reducing the detected amount of atrial fibrillation that we see with, importantly, a loop recorder in all of these patients. And also it treats the patient because there was subjective improvement in the AFEQT score and the HADS score.”
This is the first sham-controlled trial of pulsed field ablation (PFA) for atrial fibrillation, demonstrating significant reductions in arrhythmia recurrence and improvements in quality of life beyond a placebo effect. The results are generating considerable discussion about the true efficacy of this novel ablation modality.
Osmancik et al. (2026) conducted an RCT in Atrial Fibrillation (n=60). Pulsed field ablation (PFA) vs. Sham procedure was evaluated on Time to first recurrence of atrial tachyarrhythmia (posterior HR 19.6, 95% CI 6.7-76.9, p=>0.99 (posterior probability of superiority)). Pulsed field ablation was superior to sham in reducing atrial tachyarrhythmia recurrence at 6 months (6.7% vs 83.3%; posterior HR 19.6, 95% CrI 6.7-76.9; probability of superiority >0.99).