Arrhythmias & electrophysiology
Catheter ablation for symptomatic atrial fibrillation (PVI-SHAM-AF): a randomised, double-blind, sham-controlled, multicentre trial
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
Methodological detailsdouble-blind, sham-controlled, multicentre, 2:1 randomisation, 9 sites in Germany and Poland, 12-month follow-up ongoing
- Double-blind
- Sham-controlled
- Multicentre
- 2:1 randomisation
- 9 sites in Germany and Poland
- 12-month follow-up ongoing
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) |
Value
Catheter ablationmean 81.1 (SD 16.6)
Shammean 74.9 (SD 19.5)
Baseline mean (SD)
Catheter ablation61.3 (20.1)
Sham59.2 (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 |
|---|---|---|
| DeathNeither 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 | Catheter ablation: not reported in the abstract |
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.
Summarised from the published abstract; every number is checked against it