- Design
- double-blind, sham-controlled, multicentre randomised trial, 2:1 allocation
- Population
- 262 patients with symptomatic paroxysmal or persistent atrial fibrillation, median age 67
- Primary outcome
- change in AFEQT quality-of-life summary score at six months
- Effect
- between-group difference 2.6 points (95% CI -2.7 to 8.0; p=0.36)
PVI-SHAM-AF randomised 262 patients with symptomatic paroxysmal or persistent atrial fibrillation, 2:1, to catheter ablation or to a sham procedure, at nine sites in Germany and Poland. Patients and assessors were blinded. Median age was 67 and 51% were women. The primary endpoint was change at six months in the AFEQT quality-of-life score.
Both groups improved substantially. AFEQT rose from 61.3 to 81.1 after ablation and from 59.2 to 74.9 after sham. The between-group difference was 2.6 points (95% CI -2.7 to 8.0, p=0.36). Ablation did not show superiority. Serious procedure-related adverse events occurred in six ablation patients and four sham patients, and one death occurred in each arm, neither judged procedure-related.
This does not say ablation does nothing - it says that on a symptom score at six months, most of what patients experience after ablation is also produced by undergoing a procedure and being looked after. Two caveats carry weight: only 262 of 1,199 patients invited agreed to take part, so this is a self-selected group willing to risk a sham, and six months is short for a procedure sold partly on durability. Twelve-month follow-up is still running. Guidelines have not changed, and nothing here bears on ablation for rhythm control in heart failure, where the case rests on hard outcomes rather than symptoms. What it should change is the consent conversation: a patient asking how much better they will feel deserves this number.
- Quote the 2.6-point difference when consenting a patient for symptom-driven ablation.
- The confidence interval runs from -2.7 to 8.0, so a modest real benefit is not excluded.
- Six-month endpoint only; twelve-month follow-up is still running.
- Guidelines still recommend ablation for symptom relief and have not changed on this trial.
- Says nothing about ablation for rhythm control in heart failure, where the rationale is different.
Why it matters
It changes what you can honestly promise a patient about how they will feel afterwards, which is the reason most of them agree to the procedure.
Don't overread it
A non-superiority result at six months in 262 self-selected patients is not proof that ablation is ineffective.
The statistics, in plain English
A confidence interval from -2.7 to 8.0 spanning zero means the trial did not detect a difference, not that it proved there is none - a real benefit of up to 8 points remains compatible with these data, and with 262 patients the trial had limited power to rule one out. The more striking number is how much the sham group improved: 15.7 points, most of the way to the ablation group's 19.8.
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