PVI-SHAM-AF: what does this trial tell us about catheter ablation and symptoms in patients with atrial fibrillation?
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Key result
Catheter ablation fails to improve quality of life over sham in AF despite reducing recurrence.
- P not significant
- n=262
PICO
P
Population
262 patients with symptomatic paroxysmal or persistent atrial fibrillation, with a mean age of 67 years, followed for 6 months.
I
Intervention / Comparator
Catheter ablation vs Sham procedure
O
Primary Outcome
Between-group difference in change from baseline to 6 months in the Quality-of-life Questionnaire (AFEQT) summary score, p=not significant
Main Result
Absolute Event Rate: 19.8% vs 15.7%
p-value: p=not significant
Limitations
- Insufficient data on the 937 patients who declined randomization precluded a comparison with enrolled participants.
- Willingness to accept an invasive sham procedure may have selected for patients with distinct symptom burdens or treatment preferences.
- The 6-month observation period may have been too short to capture the full treatment effect of catheter ablation.
- The trial was not designed to isolate the distinct effects of placebo, Hawthorne effects, and optimized care on quality of life in the sham arm.
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“We started with the question, what is the real effect of catheter ablation on quality of life? To do this, we did a randomized multicenter double-blind trial and we found out that... catheter ablation did not prove superiority to the sham procedure for improvement in the prespecified [Atrial Fibrillation Effect on the Quality of Life Questionnaire] summary score at 6 months.”
“We had a symptomatic improvement observed after ablation, but this cannot necessarily be attributed entirely to the ablation procedure, although other sham control trials have reported an incremental quality of life benefit. Clinical counseling should consider data from sham control trials along the broader evidence base.”
“We were surprised. It probably shows that our sham was pretty good.”
Implication
Shows no significant quality-of-life benefit with catheter ablation over sham in atrial fibrillation, highlighting the therapeutic impact of comprehensive care.
Abstract
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Cite This Study
Laufs et al. (2026) conducted an editorial in Symptomatic paroxysmal or persistent atrial fibrillation (n=262). Catheter ablation vs. Sham procedure was evaluated on Between-group difference in change from baseline to 6 months in the Quality-of-life Questionnaire (AFEQT) summary score (p=not significant). Catheter ablation did not significantly improve quality of life at 6 months compared with an active sham procedure in patients with symptomatic atrial fibrillation, despite reducing arrhythmia recurrence.
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