SOLO-ESUS
(2025)Objective
To evaluate and compare the efficacy and safety of a patch-type cardiac monitoring device (PCM) versus standard 12-lead ECG in detecting atrial fibrillation in ESUS patients with left atrial enlargement.
Study Summary
• This is a protocol paper; no results have been reported yet.
• The trial plans to randomize 370 ESUS patients with LAE to 1-week continuous patch monitoring vs. single 12-lead ECG.
• Results are pending and expected to inform AF detection strategies in ESUS patients with LAE.
• The trial plans to randomize 370 ESUS patients with LAE to 1-week continuous patch monitoring vs. single 12-lead ECG.
• Results are pending and expected to inform AF detection strategies in ESUS patients with LAE.
Intervention
1-week continuous patch-type cardiac monitoring device (PCM) vs. single 12-lead electrocardiogram
Inclusion Criteria
ESUS patients with left atrial enlargement (LA diameter >40 mm in males or >38 mm in females, or LA volume index >35)
Study Design
Arms: PCM continuous monitoring for 1 week vs. single 12-lead ECG
Patients per Arm: 370 total planned (185 per arm, 1:1 randomization)
Outcome
• Primary endpoint: proportion of participants with detected AF (results pending).
• Secondary endpoints: AF burden, detection of other arrhythmias, incidence of tachycardia, bradycardia, PACs, and atrial flutter (results pending).
• Post hoc analysis planned to develop a predictive model for AF detection based on clinical and imaging data.
• Secondary endpoints: AF burden, detection of other arrhythmias, incidence of tachycardia, bradycardia, PACs, and atrial flutter (results pending).
• Post hoc analysis planned to develop a predictive model for AF detection based on clinical and imaging data.