Key result
Pulmonary vein isolation faces evaluation against sham control to test for AF placebo effects.
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““The results show that pulmonary vein isolation results in a statistically significant and clinically important decrease in AF burden, with substantial improvements in symptoms and quality of life, when compared to a sham procedure. At 6 months follow-up, the SHAM-PVI study has demonstrated no clinically relevant placebo effect with pulmonary vein isolation.””
First sham-controlled PVI trial in symptomatic AF confirms benefit beyond placebo; supports current ablation recommendations and future procedural trial design.
There are concerns that pulmonary vein isolation for atrial fibrillation may have a profound placebo effect, but no double-blind randomized clinical trials have been conducted.
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Dulai et al. (2024) studied this question. Pulmonary vein isolation was compared against a sham intervention in symptomatic atrial fibrillation due to concerns about a potential placebo effect.
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