- Design
- double-blind, sham-controlled, multicentre randomised trial, 2:1 allocation
- Population
- 262 adults with symptomatic paroxysmal or persistent atrial fibrillation; median age 67, 51% women
- Primary outcome
- change in AFEQT summary score from baseline to 6 months
- Effect
- between-group difference 2.6 points (95% CI -2.7 to 8.0), p = 0.36
PVI-SHAM-AF randomised patients with symptomatic paroxysmal or persistent atrial fibrillation 2:1 to catheter ablation or a sham procedure, double-blind, across nine sites in Germany and Poland. The endpoint was the change at six months in the AFEQT score, the standard atrial fibrillation quality-of-life instrument. Of 1,199 patients invited, 262 consented and were randomised: 173 to ablation, 89 to sham. Median age was 67 and half were women.
Both groups got better. AFEQT rose from 61.3 to 81.1 after ablation, and from 59.2 to 74.9 after sham. The between-group difference in change was 2.6 points (95% CI -2.7 to 8.0, p = 0.36). Ablation was not superior. Serious procedure-related adverse events occurred in six ablation patients and four sham patients, and there was one death in each group, neither judged procedure-related.
This is a symptom trial and should be read as one. It did not assess recurrence of atrial fibrillation, stroke, heart failure admission or mortality, and it says nothing about ablation in patients with heart failure, where the case rests on different endpoints. What it does establish is that the large symptomatic improvement patients report after ablation is mostly not attributable to the ablation — the sham arm captured about four fifths of it.
The consequence is for consent. A patient asking for ablation because they feel unwell in atrial fibrillation should be told that people randomised to a sham procedure improved nearly as much, and that this trial could not detect a symptom advantage. That is a harder conversation than the current one, and it is the accurate one.
- When consenting for ablation on symptom grounds, say that a sham-controlled trial found no significant advantage on quality of life at six months.
- Keep the rhythm, heart failure and stroke arguments for ablation separate — this trial did not test them.
- Expect substantial symptomatic improvement after any procedure for atrial fibrillation, including one that does nothing.
- Re-examine how strongly symptom relief is used to justify referral in your own practice.
- Twelve-month follow-up is still running; the six-month result is what exists now.
Why it matters
Most of what patients feel after ablation appears in people who had a sham procedure instead.
Don't overread it
This tested symptoms only, at six months, in patients without a heart failure indication — it does not speak to rhythm control, stroke or mortality.
The statistics, in plain English
A difference of 2.6 points with a 95% confidence interval from -2.7 to 8.0 means the trial cannot exclude a modest real benefit — an 8-point AFEQT gain would matter to patients — but it also cannot exclude a small harm. With 262 patients randomised out of 1,199 invited, this is a smaller trial than the question deserves, and consenting patients may differ from those who declined. It is a negative result for superiority, not proof of equivalence.
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