RecruitingNCT07347691

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

Predicting Atrial Fibrillation in Patients With Post-implantable Cardiac Monitor Implementation : A Prospective, Long-term Follow-up Study Using Comprehensive AI ECG Analysis : Multicenter Prospective Study

Sponsor

Inha University Hospital

Enrollment

92 participants

Start Date

Nov 19, 2025

Study Type

OBSERVATIONAL

Conditions

Embolic Stroke of Undetermined Source

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

Min Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is using an artificial intelligence (AI) tool to analyze heart tracings (ECGs) to predict which stroke patients are likely to develop an irregular heartbeat called atrial fibrillation (AFib). The patients in this study have had a stroke from an unknown cause (called ESUS) and have had a small device implanted under their skin to continuously monitor their heart rhythm. **You may be eligible if...** - You are 30 years or older - You have been diagnosed with a stroke of undetermined source (ESUS) - You have had or are scheduled for an implantable cardiac monitor (a small heart monitoring device placed under the skin) - You have had a standard 12-lead ECG done within 2 weeks of the monitor being placed - Your heart is in normal sinus rhythm at enrollment **You may NOT be eligible if...** - You have already been diagnosed with atrial fibrillation at any point - Your heart monitor battery is nearly depleted - Your ECG cannot be analyzed by the AI tool due to poor signal quality Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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