NCT07347691Recruiting
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
Source: ClinicalTrials.gov · Last updated 16 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 92 (estimated)
- First submitted
- 9 Jan 2026
- Start date
- 19 Nov 2025
- Primary completion date
- May 2027
- Lead sponsor
- Inha University Hospital
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT07347691
What you commit to
- Study type: Observational
- Planned participants: 92
- From 19 Nov 2025 to the primary completion date, May 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients diagnosed with Atrial Fibrillation (AF) at least once prior to the date of enrollment.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 30 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Korea University Ansan Hospital Coordinator of this site? Confirm its status | Ansan | South Korea | Recruiting |
| Inha University Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| Jeju National University Hospital Coordinator of this site? Confirm its status | Jeju City | South Korea | Recruiting |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.