Pulsed Field Ablation Versus Sham to Treat Atrial Fibrillation: The PFA-SHAM Randomized Clinical Trial

Circulation, Volume 153, Issue 25 , Page 1984-1998, June 23, 2026. 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).