Risk-Based Community Screening for the Evaluation of Atrial Fibrillation Trial (R-BEAT): a randomised controlled crossover trial protocol v1

Background: Undiagnosed atrial fibrillation is a major care-gap in stroke prevention. We describe a protocol for a randomised cross-over controlled trial evaluating a community-based approach to detecting covert atrial fibrillation, comparing routine external loop recorder monitoring with routine pulse screening, in a primary care population. Methods: We are undertaking a randomised controlled, cross-over multi-center trial in general practice comparing routine external loop recorder (ELR) cardiac monitoring (R-Test) for 1 week with usual care (pulse screening and completion of cardiac rhythm assessment if pulse is irregular). The target population is patients aged ≥55 years with CHA2DS2VASc > 2 who do not have a contraindication for oral anticoagulation, as determined by the General Practitioner. The trial is being conducted in 10 general practice sites in the West of Ireland. Participants are randomly assigned by computer generated block randomisation with variable block size to the immediate or delayed external loop recorder group assigning individual participants in a 1:1 ratio. The trial is conducted in an open-label fashion, with blinded outcome assessment. The trial also evaluates the role of serial participant self-pulse screening for detection/exclusion of atrial fibrillation. The primary outcome measure is newlydetected, and centrally confirmed cases of atrial fibrillation/flutter greater than two minutes in duration. Recruitment is ongoing. Discussion: The R-BEAT study will determine whether a 1-week ELR is associated with a greater detection rate of atrial fibrillation versus pulse screening in patients attending General Practice with a CHA2DS2VASc score of greater than 2. Trial Registration: ClinicalTrials.gov Register: NCT03911986, registered on April 11th, 2019