ArticleHeart rhythm O22025
Pulsed field ablation vs sham ablation to treat atrial fibrillation (the PFA-SHAM trial).
Article in Heart rhythm O2, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02426944 (Interventional Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in High-risk Patients With Atrial Fibrillation), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Interventional Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in High-risk Patients With Atrial Fibrillation (PRAGUE-17 Study)
Who cites it
2 citing papers in PubMed.
- Top developments in clinical cardiac electrophysiology-2025.Heart rhythm O2 · 2026Review
- Sham-controlled trials and the future of electrophysiology: Reflections on SHAM-PFA.Heart rhythm O2 · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Compared with antiarrhythmic drugs, pulmonary vein isolation (PVI) reduces atrial fibrillation (AF) recurrences and AF burden. All but one previous study was unblinded, raising the possibility of a placebo effect of catheter ablation. Objective: This study aimed to compare PVI using pulsed field (PF) energy to a sham procedure in patients with symptomatic AF. Methods: PFA-SHAM is a single-blind, randomized trial of symptomatic patients with paroxysmal or persistent AF, and an Atrial Fibrillation Effect On Quality-of-Life (AFEQT) questionnaire score ≤50. At enrollment, all patients receive an implantable cardiac monitor, and an electrophysiology study is scheduled 30 days later. After excluding supraventricular tachycardia as a cause of AF, patients are randomized to either sham or PVI using the pentaspline PF ablation catheter. The 2 co-primary outcomes are (1) freedom from recurrent AF, atrial tachycardia, or atrial flutter lasting >30 seconds, assessed as time to first recurrence (post 2-month blanking); and (2) change in quality of life according to the AFEQT score at 6-month post-ablation, compared between groups. Cross-over is permitted for patients with significant symptom worsening according to pre-specified rules. Key secondary outcomes include AF burden at 6 months, and differences in the Hospital Anxiety and Depression Scale, compared between groups. Results: Enrollment in the study was initiated in September 2023. As of January 2025, 50 patients have been enrolled. Results are expected by the end of 2025. Conclusion: This study compares PVI using PF energy to a sham procedure. The study will assess the effect of PVI on AF recurrences and quality of life. Trial registration number: NCT02426944.
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Registered trials
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