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

NCT07486739 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2026-07-29
Last updated
2026-07-23

Condition(s) studied

Atrial Fibrillation (AF)

Investigational drug(s) / intervention(s)

Artificial intelligence-enabled electrocardiographyTransthoracic Echocardiography-Guided Assessment

Artificial intelligence-enabled electrocardiography: An artificial intelligence algorithm applied to standard 12-lead electrocardiography designed to predict cardiac structural or functional abnormalities. This tool guides the decision to perform or withhold downstream echocardiography.

Transthoracic Echocardiography-Guided Assessment: Standard Transthoracic Echocardiography used to assess cardiac structure and function, serving as the reference standard for guiding clinical management in this study arm.

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Composite of all-cause Mortality, Stroke, CV Hospitalization, and AAD-Related SAEs — up to 10 years
    Evaluation of the effectiveness of the strategy based on a composite endpoint comprising the following clinical events: 1. All-cause mortality; 2. Stroke or systemic thromboembolism; 3. Hospitalization due to worsening heart failure or acute coronary syndrome; 4. Serious adverse events related to antiarrhythmic drug therapy. The endpoint is defined as the time to the first occurrence of any of these components.

Trial sites (28)

FacilityCityRegionStatus
Korea University Ansan Hospital Ansan South Korea
Hallym University Sacred Heart Hospital Anyang South Korea
Dong-A University Hospital Busan South Korea
Samsung Changwon Hospital Changwon South Korea
Dankook University Hospital Cheonan South Korea
Daegu Catholic University Medical Center Daegu South Korea
Keimyung University Dongsan Hospital Daegu South Korea
Kyungpook National University Chilgok Hospital Daegu South Korea
Chonnam National University Hospital Gwangju South Korea
Gachon University Gil Medical Center Incheon South Korea
Jeonbuk National University Hospital Jeonju South Korea
Presbyterian Medical Center (Jesus Hospital) Jeonju South Korea
CHA Bundang Medical Center Seongnam South Korea
Asan Medical Center Seoul South Korea
Boramae Medical Center Seoul South Korea
Eunpyeong St. Mary's Hospital Seoul South Korea
Ewha Womans University Seoul Hospital Seoul South Korea
Gangnam Severance Hospital Seoul South Korea
Hanyang University Hospital Seoul South Korea
Kangbuk Samsung Hospital Seoul South Korea
Korea University Guro Hospital Seoul South Korea
Kyung Hee University Hospital at Gangdong Seoul South Korea
Kyung Hee University Medical Center Seoul South Korea
Samsung Medical Center Seoul South Korea
Seoul National University Hospital Seoul South Korea
Severance Hospital Seoul South Korea
Ajou University Hospital Suwon South Korea
Pusan National University Yangsan Hospital Yangsan South Korea
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 NCT07486739 on ClinicalTrials.gov ↗ ← All trials in South Korea