AI-Read Heart Tracings Versus Routine Heart Ultrasound in Atrial Fibrillation Care
Compares AI analysis of heart tracings with routine heart ultrasound in atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Functional And STructural Assesment of the Heart by Artificial Intelligence-enabled Electrocardiogram for the Management of Atrial Fibrillation
Key facts
- Where
- Ansan, Anyang, Busan, Changwon, Cheonan, Daegu, Gwangju, Incheon, Jeonju, Seongnam, Seoul, Suwon, and Yangsan, South KoreaSee the 28 sites
Where in South Korea
- Korea University Ansan HospitalAnsan, South KoreaNo longer taking part
- Hallym University Sacred Heart HospitalAnyang, South KoreaNo longer taking part
- Dong-A University HospitalBusan, South KoreaNo longer taking part
- Samsung Changwon HospitalChangwon, South KoreaNo longer taking part
- Dankook University HospitalCheonan, South KoreaNo longer taking part
- Daegu Catholic University Medical CenterDaegu, South KoreaNo longer taking part
- Keimyung University Dongsan HospitalDaegu, South KoreaNo longer taking part
- Kyungpook National University Chilgok HospitalDaegu, South KoreaNo longer taking part
- Chonnam National University HospitalGwangju, South KoreaNo longer taking part
- Gachon University Gil Medical CenterIncheon, South KoreaNo longer taking part
- jeonbuk National University HospitalJeonju, South KoreaNo longer taking part
- Presbyterian Medical Center (Jesus Hospital)Jeonju, South KoreaNo longer taking part
- CHA Bundang Medical CenterSeongnam, South KoreaNo longer taking part
- Asan Medical CenterSeoul, South KoreaNo longer taking part
- Boramae Medical CenterSeoul, South KoreaNo longer taking part
- Eunpyeong St. Mary's HospitalSeoul, South KoreaNo longer taking part
- Ewha Womans University Seoul HospitalSeoul, South KoreaNo longer taking part
- Gangnam Severance HospitalSeoul, South KoreaNo longer taking part
- Hanyang University HospitalSeoul, South KoreaNo longer taking part
- Kangbuk Samsung HospitalSeoul, South KoreaNo longer taking part
- Korea University Guro HospitalSeoul, South KoreaNo longer taking part
- Kyung Hee University Hospital at GangdongSeoul, South KoreaNo longer taking part
- Kyung Hee University Medical CenterSeoul, South KoreaNo longer taking part
- Samsung Medical CenterSeoul, South KoreaNo longer taking part
- Seoul National University HospitalSeoul, South KoreaNo longer taking part
- Severance hospitalSeoul, South KoreaNo longer taking part
- Ajou University HospitalSuwon, South KoreaNo longer taking part
- Pusan National University Yangsan HospitalYangsan, South KoreaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Seoul National University Hospital
- Trial code
- NCT07486739
- Record updated
- 23 July 2026
- Original description
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.Read full original descriptionShow less
Functional And STructural Assesment of the Heart by Artificial Intelligence-enabled Electrocardiogram for the Management of Atrial Fibrillation
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.
Inclusion: 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; Patients for whom an initial or repeat transthoracic echocardiographic evaluation is clinically indicated; A CHA₂DS₂-VA score of ≥2; Aged ≥19 years at the time of enrollment and able to provide written informed consent voluntarily.
Exclusion: History of prior cardiac surgery; Contraindication to anticoagulation therapy; New York Heart Association (NYHA) functional class IV or European Heart Rhythm Association (EHRA) class IV symptoms; 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); History of acute coronary syndrome or coronary revascularization within the past 90 days; History of intracardiac thrombosis or systemic thromboembolism within the past 90 days; History of transient ischemic attack, ischemic stroke, or intracranial hemorrhage within the past 90 days; History of ventricular tachycardia or ventricular fibrillation; Severe chronic kidney disease (stage V), requiring or imminently requiring dialysis; 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); 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); Transthoracic echocardiography performed within the past 6 months; Ventricular rate ≥110 beats per minute during atrial fibrillation; Atrial fibrillation due to a reversible cause; Pregnancy, breastfeeding, or planning pregnancy during the study period; Life expectancy of less than 1 year; Current participation in another randomized clinical trial.