Functional And STructural Assesment of the Heart by Artificial Intelligence-enabled Electrocardiogram for the Management of Atrial Fibrillation
Trial ID: NCT07486739
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2026-05
Completion date: 2030-12-31
Sponsor: Seoul National University Hospital
Collaborators: Medical AI
Conditions: Atrial Fibrillation (AF)
Interventions: Artificial intelligence-enabled electrocardiography; Transthoracic Echocardiography-Guided Assessment
Locations: Seoul National University Hospital
Countries: South Korea
Enrollment: 1724
Age range: 19 Years - None
Sex: ALL

Summary:
The objective of this study is to evaluate whether an AI-ECG based screening strategy for detecting cardiac functional and structural abnormalities preserves clinical effectiveness and safety, compared with a conventional strategy of routine echocardiography in patients with AF, thereby demonstrating the non-inferiority of AI-ECG guided care.

Eligibility criteria:
Inclusion Criteria:

1. AF documented by electrocardiography within the past 12 months

   * AF documented on a 12-lead electrocardiogram or recorded for ≥30 seconds on a single-lead or multi-lead electrocardiogram.
2. Patients for whom an initial or repeat transthoracic echocardiographic evaluation is clinically indicated.
3. A CHA₂DS₂-VA score of ≥2.
4. Aged ≥19 years at the time of enrollment and able to provide written informed consent voluntarily.

Exclusion Criteria:

1. Transthoracic echocardiography performed within the past 6 months.
2. Ventricular rate ≥110 beats per minute during atrial fibrillation.
3. Atrial fibrillation due to a reversible cause.
4. New York Heart Association (NYHA) functional class IV or European Heart Rhythm Association (EHRA) class IV symptoms.
5. Known history of structural heart disease or clinical findings suggestive of structural heart disease based on medical history and physical examination. (e.g., presence of a cardiac murmur of Levine scale grade 3 or higher on auscultation, or murmurs suggestive of moderate to severe mitral stenosis, such as an opening snap or diastolic rumbling murmur).
6. Baseline electrocardiographic conduction abnormalities or significant electrocardiographic findings suggestive of clinically meaningful structural heart disease (e.g., Mobitz type II second-degree atrioventricular block, third-degree atrioventricular block, or QTc ≥480 ms).
7. History of prior cardiac surgery.
8. History of acute coronary syndrome or coronary revascularization within the past 90 days.
9. History of intracardiac thrombosis or systemic thromboembolism within the past 90 days.
10. History of transient ischemic attack, ischemic stroke, or intracranial hemorrhage within the past 90 days.
11. History of ventricular tachycardia or ventricular fibrillation.
12. Severe liver disease associated with coagulopathy (e.g., AST or ALT \>3× the upper limit of normal, or total bilirubin \>2× the upper limit of normal).
13. Severe chronic kidney disease (stage V), requiring or imminently requiring dialysis.
14. Contraindication to anticoagulation therapy.
15. Pregnancy, breastfeeding, or planning pregnancy during the study period.
16. Life expectancy of less than 1 year.
17. Current participation in another randomized clinical trial.

Outcomes:
Composite of all-cause Mortality, Stroke, CV Hospitalization, and AAD-Related SAEs