About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Artificial intelligence-enabled electrocardiography
- Transthoracic Echocardiography-Guided Assessment
Treatment groups
Sponsors and collaborators
Seoul National University Hospital
Lead sponsor
Medical AI
Collaborator