- Design
- randomised, double-blind, sham-controlled, multicentre trial, 2:1 allocation
- Population
- 262 adults with symptomatic paroxysmal or persistent atrial fibrillation; median age 67, 51% women
- Primary outcome
- change in AFEQT quality-of-life summary score at 6 months
- Effect
- between-group difference 2.6 points (95% CI -2.7 to 8.0), p=0.36
Guidelines recommend catheter ablation for symptom relief in atrial fibrillation. A double-blind trial at nine sites in Germany and Poland randomised 262 patients with symptomatic paroxysmal or persistent atrial fibrillation 2:1 to ablation or a sham procedure. Median age was 67 and 51% were women. The primary endpoint was change in the AFEQT quality-of-life summary score at six months.
Both groups improved substantially. Scores rose from 61.3 to 81.1 with ablation and from 59.2 to 74.9 with sham. The between-group difference, by Hodges-Lehmann estimate, was 2.6 points (95% CI -2.7 to 8.0, p=0.36). One death occurred in each arm, neither procedure-related; serious adverse events judged related or possibly related occurred in six ablation and four sham patients, the latter including an ischaemic stroke.
Read this carefully, because it is easy to overstate in both directions. It does not show ablation is ineffective at maintaining sinus rhythm, and it does not touch the trials of ablation in heart failure or its effect on atrial fibrillation burden. What it shows is that the symptom benefit - the specific indication guidelines cite - was not distinguishable from an elaborate placebo over six months in a trial of this size. That is a direct challenge to how the procedure is offered, and the consent conversation is where it lands first. Twelve-month follow-up is ongoing.
- When offering ablation for symptoms alone, present this trial rather than only the single-arm improvement figures.
- Distinguish rhythm control and burden reduction from symptom relief - this trial addressed only the last.
- Do not apply the result to ablation indications in heart failure, where separate trial evidence exists.
- Note that the sham arm had real complications, including a stroke: the comparator was a genuine invasive procedure.
- Given the cost and limited access to electrophysiology services in India, this strengthens the case for optimising medical therapy and rate control first.
Why it matters
The guideline indication for ablation is symptom relief, and this is the first double-blind test of exactly that claim.
Don't overread it
This tested symptoms at six months, not rhythm control, atrial fibrillation burden, stroke or mortality, and it does not overturn ablation indications supported by separate trials.
The statistics, in plain English
The confidence interval runs from -2.7 to 8.0, which includes zero - so a real advantage of up to 8 points cannot be excluded, and neither can a small disadvantage. With 262 patients this trial was not large enough to rule out a modest benefit, and that is a different claim from proving there is none. The more telling figure is the 15.7-point rise in the sham arm: most of what patients experience after this procedure is not attributable to the ablation.
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