The SHAM-PVI study is an ongoing double-blind randomized trial of 140 patients designed to compare pulmonary vein isolation to a sham procedure for reducing total atrial fibrillation burden at 6 months.
RCT (n=140)
Double-blind
randomized
Does pulmonary vein isolation reduce total AF burden in patients with symptomatic paroxysmal or persistent AF compared to a sham procedure?
This study design paper outlines a double-blind, sham-controlled randomized trial to evaluate the true efficacy of pulmonary vein isolation on AF burden, accounting for potential placebo effects.
INTRODUCTION: Pulmonary vein (PV) isolation has been shown to reduce atrial fibrillation (AF) burden and symptoms in patients. However, to date previous studies have been unblinded raising the possibility of a placebo effect to account for differences in outcomes. HYPOTHESIS & METHODS: The objective of this study is to compare PV isolation to a sham procedure in patients with symptomatic AF. The SHAM-PVI study is a double blind randomized controlled clinical trial. 140 patients with symptomatic paroxysmal or persistent AF will be randomized to either PV isolation (with cryoballoon ablation) or a sham procedure (with phrenic nerve pacing). All patients will receive an implantable loop recorder. The primary outcome is total AF burden at 6 months postrandomisation (excluding the 3 month blanking period). Key secondary outcomes include (1) time to symptomatic and asymptomatic atrial tachyarrhythmia (2) total atrial tachyarrhythmia episodes and (3) patient reported outcome measures. RESULTS: Enrollment was initiated in January 2020. Through April 2023 119 patients have been recruited. Results are expected to be disseminated in 2024. CONCLUSION: This study compares PV isolation using cryoablation to a sham procedure. The study will estimate the effect of PV isolation on AF burden.
Dulai et al. (Tue,) conducted a rct in Symptomatic atrial fibrillation (n=140). Pulmonary vein isolation (cryoballoon ablation) vs. Sham procedure (phrenic nerve pacing) was evaluated on Total AF burden at 6 months postrandomisation (excluding the 3 month blanking period). The SHAM-PVI study is an ongoing double-blind randomized trial of 140 patients designed to compare pulmonary vein isolation to a sham procedure for reducing total atrial fibrillation burden at 6 months.