Arrhythmias & electrophysiologyRandomised controlled trial
Pulsed Field Ablation Versus Sham to Treat Atrial Fibrillation: The PFA-SHAM Randomized Clinical Trial
- Randomised controlled trial
- sham-controlled
- single-blind
- blinded end-point assessment
- prospective
All participants received implantable cardiac monitors for continuous rhythm monitoring
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
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:10.1161/circulationaha.126.079484
Summarised from the published abstract; every number is checked against it