Arrhythmias & electrophysiologyRandomised controlled trial
Catheter ablation for symptomatic atrial fibrillation (PVI-SHAM-AF): a randomised, double-blind, sham-controlled, multicentre trial
- Randomised controlled trial
- double-blind
- sham-controlled
- multicentre
- 2:1 randomisation
- 9 sites in Germany and Poland
- 12-month follow-up ongoing
Authors' conclusion
Catheter ablation did not demonstrate superiority over a sham procedure for improving atrial fibrillation-related quality of life at 6 months.
Study context
- Population
- Adults (≥18 years) with symptomatic paroxysmal or persistent AF1,199 invited
- Participants
- 262 adults
- Comparison
- Catheter ablation vs sham procedure
- Catheter ablationn = 173
- Shamn = 89reference
- Primary endpoint
- Between-group difference in change from baseline in AFEQT summary score
- Follow-up
- 6 months
Primary result
As reported in the abstract
AFEQT summary score
| Group | Value | Baseline mean (SD) |
|---|---|---|
| Catheter ablation | mean 81.1 (SD 16.6) | 61.3 (20.1) |
| Sham | mean 74.9 (SD 19.5) | 59.2 (19.0) |
- Hodges-Lehmann estimate of between-group difference in change
- 2.6 (95% CI −2.7 to 8.0; p=0.36)
Further findings
events
| Outcome | Catheter ablation | Sham |
|---|---|---|
| Death · neither considered procedure-related | 1 | 1 |
Safety
| Outcome | Catheter ablation | Sham |
|---|---|---|
| Procedure-related or possibly related serious adverse events | ||
| Ischaemic stroke | Not reported in the abstract | 1 |
Original publication
Catheter ablation for symptomatic atrial fibrillation (PVI-SHAM-AF): a randomised, double-blind, sham-controlled, multicentre trial. Lancet. Published 30 August 2026. doi:10.1016/s0140-6736(26)01558-8
Summarised from the published abstract; every number is checked against it