Functional And STructural Assesment of the Heart by Artificial Intelligence-enabled Electrocardio… (NCT07486739) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Functional And STructural Assesment of the Heart by Artificial Intelligence-enabled Electrocardiogram for the Management of Atrial Fibrillation
South Korea1,724 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. AF documented by electrocardiography within the past 12 months
✓. 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 criteria
✕. Transthoracic echocardiography performed within the past 6 months.
✕. Ventricular rate ≥110 beats per minute during atrial fibrillation.
✕. Atrial fibrillation due to a reversible cause.
✕. 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).
✕. 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).
✕
What they're measuring
1
Composite of all-cause Mortality, Stroke, CV Hospitalization, and AAD-Related SAEs