Remote ischemic preconditioning in a setting of electrical cardioversion of early onset persistent atrial fibrillation (RIP CAF trial): Rationale and study design

Abstract

BackgroundThe beneficial effect of remote ischemic preconditioning (RIP) on electrophysiological parameters resulting in lower inducibility and sustainability of atrial fibrillation (AF) in patients with paroxysmal AF has been recently demonstrated in a randomized trial. However, the potential clinical impact of RIP on persistent AF (CAF) has not been investigated. Therefore, we designed a randomized trial set in a setting of electrical cardioversion (CV) of early onset CAF. AimThe aim of the study is to answer the following questions: I) Does RIP have impact on rate of spontaneous conversion into sinus rhythm (SR) within 24 h after first RIP intervention? II) Does RIP have the potential to improve the acute outcome of CV following a standardized protocol? MethodsThe presented study is a two-armed randomized, placebo-controlled, double-blinded, multi-center trial in a cohort of 588 patients with early onset CAF referred for electrical CV. The patients will undergo 3 sessions (immediately after randomization, the following morning, and directly before scheduled CV 24 h after randomization) of either RIP intervention or a sham procedure. The primary outcome of the study, i.e. documentation of SR 24 h after randomization as well secondary outcome i.e. stable SR first CV without usage of anti-arrhythmic drugs will be documented by 12-lead surface electrocardiography. ConclusionPreviously observed positive effect of RIP on atrial electrophysiology might be also implemented in a clinical setting of CV and therefore simplified and improve patient treatment.