Arrhythmias & electrophysiology
Pulsed Field Ablation Versus Sham to Treat Atrial Fibrillation: The PFA-SHAM Randomized Clinical Trial
Authors' conclusion
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.
Study context
- Population
- Patients with highly symptomatic atrial fibrillation (AF) (AFEQT score <50)
- Participants
- 60 patients
- Comparison
- Pulsed field ablation (PFA) vs sham procedure
- Primary endpoint
- Co-primary: (1) time to first recurrence of atrial tachyarrhythmia; (2) change from baseline in AFEQT score
- Follow-up
- 6 months
Methodological detailssham-controlled, single-blind, blinded end-point assessment, prospective, All participants received implantable cardiac monitors for continuous rhythm monitoring
- Sham-controlled
- Single-blind
- Blinded end-point assessment
- Prospective
- All participants received implantable cardiac monitors for continuous rhythm monitoring
Primary result
As reported in the abstract
AF recurrence; change in AFEQT score
PFA vs ShamPosterior HR (95% CrI)
AF recurrence; CrI; posterior probability of superiority >0.99
19.6(6.7–76.9)
PFA vs ShamPosterior median difference (95% CrI)
AFEQT change; CrI; posterior probability of superiority >0.99
32.6(20.2–44.9)
Secondary outcomes
| Outcome | PFA | Sham | Median difference (95% CrI) | |
|---|---|---|---|---|
| AF burden · 6 months · CrI; posterior probability of superiority >0.99 | 0 (range 0–0) | 0.43 (range 0.04–3.47) | −0.39 (−2.5 to −0.1) | |
| HADS score change · CrI; posterior probability of superiority >0.99 | −4 (range −7.8–-2.0) points | −0.5 (range −4.5–1.0) | −3.5 (−6.0 to −1.0) | |
| −10−505Difference (linear scale) |
Original publication
Pulsed Field Ablation Versus Sham to Treat Atrial Fibrillation: The PFA-SHAM Randomized Clinical Trial. Circulation. Published 26 May 2026. doi:10.
Summarised from the published abstract; every number is checked against it