- Question
- Does catheter ablation improve atrial fibrillation-related quality of life more than a sham procedure?
- Design
- Randomized, double-blind, multicenter trial with 2:1 allocation at nine sites in Germany and Poland; 262 patients were randomized. Median follow-up was 184 days.
- Population
- Adults aged 18 years or older with symptomatic paroxysmal or persistent atrial fibrillation. Median age was 67 years and 51% were female.
- Intervention
- Catheter ablation (pulmonary vein isolation by radiofrequency or cryoablation per local standards) within 48 hours of baseline evaluation; 173 patients.
- Control
- A sham procedure with deep sedation and femoral vascular puncture but no ablation; 89 patients.
- Primary outcome
- Between-group difference in change from baseline to 6 months in the AFEQT (Atrial Fibrillation Effect on Quality-of-life) summary score.
- Results
- The AFEQT score rose from 61.3 to 81.1 with ablation and from 59.2 to 74.9 with sham. The between-group difference in change (Hodges-Lehmann estimate) was 2.6 (95% CI -2.7 to 8.0; p=0.36).
- Safety
- There was one death in each group, neither considered related to the procedure. Serious adverse events judged related or possibly related occurred in six patients in the ablation group and four in the sham group, including one ischemic stroke in the sham group.
- Conclusion
- Catheter ablation did not show superiority over a sham procedure for improving quality of life at 6 months.
- Why it matters
- This is one of the few sham-controlled trials of atrial fibrillation ablation and provides evidence on the placebo component of patient-reported outcomes. It encourages cautious interpretation of symptom benefits seen in unblinded trials; 12-month follow-up is still ongoing.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026