Catheter ablation did not demonstrate superiority over a sham procedure for improving atrial fibrillation-related quality of life at 6 months.
Key Findings
Results
Catheter ablation did not significantly improve atrial fibrillation-related quality of life compared to a sham procedure at 6 months.
The Hodges-Lehmann estimate of the between-group difference in change in AFEQT summary score was 2.6 (95% CI -2.7 to 8.0; p=0.36).
Mean AFEQT summary score increased from 61.3 (SD 20.1) to 81.1 (16.6) in the catheter ablation group.
Mean AFEQT summary score increased from 59.2 (SD 19.0) to 74.9 (19.5) in the sham control group.
Both groups showed substantial within-group improvement in quality of life, but the between-group difference was not statistically significant.
The primary analysis was conducted in the intention-to-treat population with missing data handled by multiple imputation.
Methods
The trial enrolled 262 patients randomised 2:1 to catheter ablation or sham procedure across nine sites in Germany and Poland.
173 patients were assigned to catheter ablation and 89 to the sham control group.
1199 patients were invited to participate between Nov 12, 2021, and Nov 3, 2025; 262 consented and were randomly assigned.
Median age was 67 years (IQR 62-73); 134 (51%) were female and 128 (49%) were male.
Patients had symptomatic paroxysmal or persistent atrial fibrillation and were aged 18 years or older.
Randomisation used an automated online system with variable block sizes, stratified by trial site.
Methods
Median follow-up was 184 days at the time of the primary analysis, with 12-month follow-up ongoing.
Median follow-up was 184 days (IQR 181-191).
The primary endpoint was assessed at 6 months.
12-month follow-up is ongoing and registered with ClinicalTrials.gov (NCT05119231).
Results
One death occurred in each group, neither considered related to the study procedure.
One death occurred in the catheter ablation group and one in the sham control group.
Neither death was considered related to the study procedure.
Serious adverse events adjudicated as related or possibly related to the study procedure occurred in ten unique patients: six in the catheter ablation group and four in the sham control group.
One ischaemic stroke occurred in the sham control group and was adjudicated as related or possibly related to the study procedure.
Results
Both treatment groups demonstrated large within-group improvements in AFEQT scores from baseline to 6 months.
The catheter ablation group improved by approximately 19.8 AFEQT points (from 61.3 to 81.1).
The sham group improved by approximately 15.7 AFEQT points (from 59.2 to 74.9).
Both groups started with similar baseline AFEQT scores (61.3 vs 59.2), indicating comparable symptom burden at enrollment.
The substantial improvement in the sham group suggests a significant placebo or regression-to-the-mean effect in this population.
Methods
The trial was designed as a double-blind, sham-controlled study to isolate the specific effect of catheter ablation beyond placebo.
The trial used a sham procedure as the comparator to control for placebo effects, which is uncommon in ablation trials.
The double-blind design aimed to prevent patients and outcome assessors from knowing treatment assignment.
The primary endpoint was the AFEQT summary score, a validated patient-reported outcome measure for atrial fibrillation-related quality of life.
Guidelines currently recommend catheter ablation for symptom relief in patients with atrial fibrillation, making this sham-controlled design a direct test of that recommendation.
What This Means
This research suggests that catheter ablation — a procedure that uses heat or cold energy delivered through a catheter to destroy heart tissue causing abnormal electrical signals in atrial fibrillation — did not improve patients' quality of life significantly more than a fake (sham) procedure at six months. In the study, 262 patients with symptomatic atrial fibrillation were randomly assigned to either real catheter ablation or a sham procedure where patients underwent the same preparation and sedation but no actual ablation was performed. Both groups reported large improvements in their atrial fibrillation-related quality of life over six months, but the difference between the two groups was small and not statistically significant (a difference of about 2.6 points on a 100-point scale, which could easily be due to chance).
The large improvement seen in the sham group — roughly 16 points on a validated quality-of-life scale — highlights how much of the perceived benefit from catheter ablation in previous unblinded studies may have been due to placebo effects, patient expectations, or the natural course of the disease rather than the procedure itself. This finding is particularly important because current cardiology guidelines recommend catheter ablation specifically for symptom relief, and this trial directly challenges that evidence base by showing that a sham procedure produced nearly as much symptomatic benefit.
This research matters because catheter ablation is widely performed, carries procedural risks (including serious adverse events in about 4% of patients in this trial), and is resource-intensive. The trial's 12-month follow-up data are still being collected, which may provide additional insights, and the study authors note that longer-term outcomes or effects on heart rhythm itself (rather than just symptoms) were not the focus of this report. These results suggest that the symptomatic benefit of catheter ablation previously reported in non-blinded trials may have been substantially overestimated.