Key result
Sham ablation links higher AF burden to worse quality of life, arguing against a placebo effect.
Why the study?
The temporal evolution of the relationship between AF burden and quality of life following a sham ablation procedure, particularly regarding the placebo effect, had not been thoroughly explored.
Does a sham ablation procedure induce a placebo effect by altering the relationship between atrial fibrillation burden and patient-reported quality of life in patients with symptomatic atrial fibrillation?
RCT (n=30)
Sham-controlled
Randomized
Does a sham ablation procedure induce a placebo effect by altering the relationship between atrial fibrillation burden and patient-reported quality of life in patients with symptomatic atrial fibrillation?
Patients undergoing a sham AF ablation procedure maintained a significant negative correlation between objective AF burden and quality of life at 3 and 6 months, refuting a sustained procedural placebo effect on symptom perception.
Sham ablation preserves AF burden-QoL correlation; leaves open the magnitude of placebo effects in future ablation trials.
Background The PFA-SHAM trial demonstrated that pulsed-field ablation (PFA) for atrial fibrillation (AF) reduces AF burden and improves quality of life (QoL). However, the temporal changes in the relationship between AF burden and QoL following a sham procedure have not been thoroughly explored, particularly regarding the placebo effect. Objectives This study sought to investigate a temporal evolution of the relationship between AF burden and patient-reported QoL outcomes in patients who underwent a sham procedure. Methods This is a post hoc analysis of the PFA-SHAM trial, which in total involved 60 patients with symptomatic paroxysmal or persistent AF. Participants were randomly assigned to receive either a PFA procedure or a sham procedure. An implantable loop recorder was used to continuously monitor the AF burden (all the episodes were manually checked). The QoL was evaluated using the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire at baseline and at 2, 3, and 6 months post-procedure. We analysed the associations between AF burden and QoL using correlation analysis. Only the patients who underwent a sham procedure were included in this post hoc analysis. Results A total of 30 patients (66.7 ± 9.5 years, 17 [56.7%] females, 23 [76.7%] paroxysmal AF) were included. The median AF burden was 0.02% (IQR: 0-0.1) at 0-2 months, 0.67% (IQR: 0-0.7) at 2-3 months, and 0.13% (IQR: 0-0.21) at 3-6 months (p = 0.29). We found a significant negative correlation between the AF burden and QoL at both 3 and 6 months post-procedure, with correlation coefficients of R = -0.55 (p = 0.002) and R = -0.37 (p = 0.046), respectively. Conclusions Patients who underwent a sham procedure exhibited a significant negative correlation between AF burden and QoL at 3 months after the procedure, which persisted at 6 months. These findings do not support the existence of a significant placebo effect associated with the procedure.
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Hozman et al. (2026) conducted an RCT in Symptomatic paroxysmal or persistent atrial fibrillation (n=30). Sham ablation procedure was evaluated on Correlation between AF burden and quality of life (AFEQT score) at 3 and 6 months post-procedure (R = -0.55 at 3 months; R = -0.37 at 6 months, p=0.002 at 3 months; 0.046 at 6 months). Sham ablation for AF showed a negative correlation between AF burden and quality of life at 3 months (R=-0.55, p=0.002) and 6 months (R=-0.37, p=0.046), arguing against a major placebo effect.
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