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May 26, 2026Circulation
Pulsed Field Ablation Versus Sham to Treat Atrial Fibrillation: The PFA-SHAM Randomized Clinical Trial
Key result
Pulsed field ablation cuts 6-month atrial tachyarrhythmia recurrence by ~92% versus sham.
Why the study?
Prior AF ablation studies were largely unblinded, leaving residual concerns about placebo effects on AF recurrence and subjective outcomes such as quality of life or anxiety.
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?
Key Points
- This trial aims to assess the effectiveness of pulsed field ablation compared to a sham procedure in treating symptomatic atrial fibrillation.
- Randomized controlled trial with patients assigned to either pulsed field ablation or sham procedure.
- Used implantable cardiac monitors for continuous rhythm monitoring during follow-up.
- Co-primary outcomes assessed were AF recurrence and changes in quality of life scores over 6 months.
- AF recurrence at 6 months occurred in 6.7% of PFA patients versus 83.3% in sham (HR 19.6, 95% CI 6.7-76.9).
- Quality of life scores increased by 43.9 points in PFA versus 11.3 points in sham (median difference 32.6, 95% CI 20.2-44.9).
- AF burden at 6 months was lower in PFA patients (0) compared to sham (0.43), with a median difference of -0.39 (95% CI -2.5 to -0.1).
Study Design
Type
RCT (n=60)
Blinding
Single-blind
Randomization
1:1
Structured PICO
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?
P
Population
60 patients with highly symptomatic atrial fibrillation (Atrial Fibrillation Effect on Quality-of-Life score <50)
I
Intervention
Pulsed field ablation (PFA)
C
Comparator
Sham procedure
O
Outcome
6-month co-primary outcomes: (1) time to first recurrence of atrial tachyarrhythmia and (2) changes from baseline in Atrial Fibrillation Effect on Quality-of-Life scores
Main Result
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)
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.
Discussion
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
DMDaniel MorinCardiologist, University of California San Francisco
“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.”
“On the one hand, we wanted to do a sham trial. On the other hand, we really wanted to minimise the number of patients in the trial, partly to minimise the exposure of a lot of patients to a sham procedure. So as part of the inclusion, exclusion criteria, we required patients to be highly symptomatic. And that was defined by a baseline AFEQT score of less than 50. So we brought in a very high risk population.”
Implication
PFA markedly outperforms sham for AF recurrence and QoL; confirms ablation benefit beyond placebo in symptomatic patients.
Abstract
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 <50). Patients were assigned 1:1 to PFA or a sham procedure. All participants received implantable cardiac monitors for continuous rhythm monitoring during follow-up. The 6-month co-primary outcomes were (1) time to first recurrence of atrial tachyarrhythmia and (2) changes from baseline in Atrial Fibrillation Effect on Quality-of-Life scores compared between groups. Secondary outcomes were AF burden and psychological distress (assessed by the Hospital Anxiety and Depression Scale [HADS]). RESULTS: Patients (n=60) were randomized to PFA or sham. At 6 months, the first co-primary end point of AF recurrence was met in 2 patients (6.7%) who underwent PFA and 25 patients (83.3%) who underwent sham (posterior hazard ratio, 19.6 [95% bayesian credible intervals, 6.7-76.9]; posterior probability of superiority >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.
Cite This Study
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).