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

Prior treatment

• History of prior cardiac surgery.
• Contraindication to anticoagulation therapy.

Other illness

• 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.

Lab values

• 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).

Other

• 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.

• 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.