Rationale and Design of the Efficacy and Safety of a Patch-Type Cardiac Monitor for Diagnosing Paroxysmal Atrial Fibrillation in Embolic Stroke of Undetermined Source Patients with Left Atrial Enlargement (SOLO-ESUS): A Randomized Controlled Trial

Abstract

Introduction: Detecting atrial fibrillation (AF) in patients with embolic stroke of undetermined source (ESUS) is crucial for effective secondary stroke prevention, particularly in those with left atrial enlargement (LAE), as they have a higher risk of subclinical AF. This study aimed to evaluate and compare the efficacy and safety of a patch-type cardiac monitoring device (PCM) in detecting AF in ESUS patients with LAE. Methods: This prospective, multicenter, open-label, randomized, controlled, investigator-initiated trial will recruit a total of 370 ESUS patients with LAE and randomize them in a 1:1 ratio into two groups: the intervention group, which will receive continuous monitoring with the PCM for 1 week, and the control group, which will undergo a single 12-lead electrocardiogram. LAE will be defined as a left atrial diameter greater than 40 mm in males and greater than 38 mm in females or a left atrial volume index exceeding 35. The primary endpoint is the proportion of participants with detected AF. Secondary endpoints include AF burden, detection of other arrhythmias, and the incidence of tachycardia, bradycardia, premature atrial contractions, and atrial flutter. A post hoc analysis will explore factors influencing AF detection and aim to develop a predictive model based on clinical and imaging data. Conclusion: This trial is expected to provide valuable insights into the safety and efficacy of PCM in detecting AF, potentially influencing clinical strategies for AF detection and management in ESUS patients with LAE.