Clinical Trial

AI-Based Prediction of Atrial Fibrillation in ESUS Patients With ICM

Study acronym: SMART-ESUS
Recruiting
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Summary
This study investigates patients with Embolic Stroke of Undetermined Source (ESUS) who have received an Implantable Cardiac Monitor (ICM). The main purpose is to evaluate the predictive value of an Artificial Intelligence ECG analysis tool, named SmartECG-AF. Participants will be classified into two groups based on the AI analysis: a "High Risk" group and a "Low to Intermediate Risk" (control) group. The study aims to compare the incidence rate of atrial fibrillation (AF) events over time between these two groups. Additionally, the study will analyze the relationship between the AI-predicted risk levels and the occurrence of major cardiovascular events during the follow-up period.
Trial Details
NCT Number NCT07347691
Lead Sponsor Inha University Hospital
Collaborators: DeepCardio Co., Ltd.
Conditions Embolic Stroke of Undetermined Source
Enrollment 92 participants
Start Date 2025-11-19
Primary Completion 2027-05 (estimated)
Study Completion 2028-05 (estimated)
Updated on ClinicalTrials.gov 2026-01-16