A randomized sham‐controlled study of pulmonary vein isolation in symptomatic atrial fibrillation (The SHAM‐PVI study): Study design and rationale

Abstract

AbstractIntroductionPulmonary 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 & MethodsThe 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.ResultsEnrollment was initiated in January 2020. Through April 2023 119 patients have been recruited. Results are expected to be disseminated in 2024.ConclusionThis study compares PV isolation using cryoablation to a sham procedure. The study will estimate the effect of PV isolation on AF burden.