Not_yet_recruitingNANCT07486739

Functional And STructural Assesment of the Heart by Artificial Intelligence-enabled Electrocardiogram for the Management of Atrial Fibrillation

Sponsor: Seoul National University Hospital

Trial Details

ConditionAtrial Fibrillation (AF)
InterventionArtificial intelligence-enabled electrocardiography; Transthoracic Echocardiography-Guided Assessment
PhaseNA
StatusNot_yet_recruiting
Participants1,724
Est. Completion31 Dec 2030
Last Updated23 July 2026

Primary Outcome

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

Eligibility Criteria

Inclusion 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.

Trial Sites

Countries

South Korea
View Registry Entry

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