Atrial Fibrillation Validation Among Patients with Ischemic Stroke: An Electrocardiogram Comparison Between 24 h Holter and Single-Lead Wearable Devices: Rationale and Design of the AVANT-GARDE Trial

Introduction/Aim: As the prevalence of atrial fibrillation (AF) increases with the aging population, the challenge of enhancing the detection rate of AF in embolic stroke of undetermined source (ESUS) has intensified. AF is often detected only after a debilitating or fatal cardioembolic stroke, underscoring the crucial need for early identification to prevent further ischemic stroke (IS). This study aims to assess the efficacy of AF detection in patients with ESUS using a single-lead patch (mobiCARE™; Seers Tech, Inc.) over a period of at least 72 h and up to 5 days, in comparison with standard 24 h Holter monitoring. Design: This multicenter, prospective, consecutive observational trial involves patients aged 18 years and older who have experienced an IS within the past six months. Study outcomes: The primary outcome is the initial detection of AF using either a single-lead wearable patch or 24 h Holter monitoring at both baseline and at a 6-month follow-up among patients diagnosed with ESUS stroke. Secondary outcomes include the first detection of AF among stroke patients with large-artery atherosclerosis or small-vessel occlusion, particularly those whose transthoracic echocardiography reveals a left atrial size of ≥44 mm, an echocardiographic marker of AF. Discussion: Prolonged cardiac monitoring increases the detection rate of paroxysmal AF, but the optimal method should be non-invasive, patient-friendly, and accurate. This new technology may reduce patient burden and socioeconomic impact by facilitating AF detection and preventing cardioembolic stroke, even in patients with non-cardiogenic stroke.