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

NCT07347691 · tracked via the Priya Life Science South Korea tracker

Sponsor

Inha University Hospital

Phase

Observational

Started

2025-11-19

Last updated

2026-01-16

Condition(s) studied

Embolic Stroke of Undetermined Source

Study 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.

Eligibility

Sex

ALL

Min age

30 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients aged 30 years or older. * Patients diagnosed with Embolic Stroke of Undetermined Source (ESUS) who have undergone or are scheduled for Implantable Cardiac Monitor (ICM) implantation. * Patients who have undergone at least one 12-lead ECG examination within 2 weeks before or after the date of ICM implantation. * Patients maintaining Sinus Rhythm on ECG at the time of enrollment. * Patients who have voluntarily signed the informed consent form. Exclusion Criteria: * Patients diagnosed with Atrial Fibrillation (AF) at least once prior to the date of enrollment. * Patients whose ICM battery status is at Elective Replacement Interval (ERI), making recording impossible. * Patients whose ECGs cannot be analyzed by the AI algorithm (SmartECG-AF) due to severe artifacts or noise, or are incompatible with digital analysis.

Primary outcome measure(s)

Incidence of Atrial Fibrillation (Time-to-Event) — Up to 12 months
Comparison of the cumulative incidence rate of atrial fibrillation (AF) events between the High Risk group and the Low to Intermediate Risk group (classified by SmartECG-AF). AF occurrence is confirmed by reviewing data recorded on the Implantable Cardiac Monitor (ICM).

Trial sites (5)

Facility	City	Region	Status
Korea University Ansan Hospital	Ansan	South Korea	Recruiting
Inha University Hospital	Incheon	South Korea	Recruiting
Jeju National University Hospital	Jeju City	South Korea	Recruiting
Korea University Guro Hospital	Seoul	South Korea	Recruiting
Ajou University Hospital	Suwon	South Korea	Recruiting

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Other trials for the same condition

Atrial Fibrillation Detection Using MEMO Patch in Patients With Stroke of Unknown Cause Recruiting

Prospective Registry of Elderly ESUS With PFO Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07347691 on ClinicalTrials.gov ↗ ← All trials in South Korea