Catheter ablation for atrial fibrillation (AF) did not significantly improve AF-related quality of life compared with a sham procedure, despite reducing AF recurrence, as per the main findings of the PVI-SHAM-AF trial presented at the 2026 European Society of Cardiology (ESC) congress (28–31 August, Munich, Germany) and published simultaneously in The Lancet.
The PVI-SHAM-AF trial was led by Rolf Wachter (University of Leipzig Medical Centre, Leipzig, Germany) and Nikolaos Dagres (German Heart Centre at Charité-University Medical Centre Berlin, Berlin, Germany).
“While it is well established that catheter ablation improves rhythm control and delays AF progression, we do not have conclusive evidence that catheter ablation impacts patients’ quality of life related to their AF,” said Dagres. “To rule out whether there is a ‘placebo effect’ associated with the procedure, we conducted the PVI-SHAM-AF trial specifically to investigate improvements in AF-related quality of life with catheter ablation compared with a sham procedure.”
PVI-SHAM-AF was a double-blind trial conducted at nine sites in Germany and Poland. In total, 262 patients with symptomatic paroxysmal or persistent AF were randomised 2:1 to undergo catheter ablation or a sham procedure. During the sham procedure, patients received conscious sedation for the same length of time and in the same setting as the standard procedure, and, while vascular access was obtained, no catheter was placed.
Participants completed the AF effect on the quality of life questionnaire (AFEQT) at baseline and at six months, answering questions on their quality of life specifically related to AF. The primary endpoint was the change from baseline to six months in AFEQT summary scores.
The researchers found that the AFEQT summary score improved in both groups but with no significant difference between them. The AFEQT summary score improved from 61.3 to 81.1 in the ablation group and from 59.2 to 74.9 in the sham group (p=0.36). Additionally, freedom from AF after six months was substantially higher in the catheter ablation group compared with the sham group (73% vs 52%, respectively).
There were a total of five vascular access complications—three in the catheter ablation group and two in the sham group. Serious adverse events related or possibly related to the study procedure occurred in six patients in the ablation group and four patients in the sham group.
Regarding limitations, the researchers note that 937 out of 1,199 patients invited to participate in the trial declined.
“Willingness to accept sham allocation may have selected patients with different symptom burden, treatment expectations or preferences,” Dagres commented.
According to the researchers, some more severely symptomatic patients may have declined to participate because they preferred catheter ablation and, thus, selection bias may have played an important role in the outcome of this study.
“While patients often say that their quality of life has improved after a procedure, it appears from our trial findings that most of this improvement is not attributable to the catheter ablation, but to other factors,” Wachter concluded. “These could include a placebo effect, optimisation of therapies or other factors. Catheter ablation delays progression of AF but we can now use these data when we discuss what other benefits patients may expect from catheter ablation.”
