"The DEEP-AF study is a prospective, multi-center, randomized clinical trial evaluating the effectiveness of an artificial intelligence-enhanced electrocardiography algorithm (SmartECG-AFrisk) for early detection of atrial fibrillation (AF) in adults with suspected AF but no prior diagnosis. A total of 1,230 participants will be enrolled across 13 centers in Korea and randomized 1:1 into standard care or AI-guided care arms. In the standard care arm, diagnostic evaluation follows clinical guidelines with symptom-based use of 12-lead ECG, Holter, or patch ECG. In the AI-guided arm, baseline 12-lead ECGs are analyzed using SmartECG-AFrisk to calculate an AF risk score. Participants are classified as high-risk (score ≥50) or low-risk (\<50), and monitoring strategies are determined accordingly, enabling targeted ECG monitoring for high-risk individuals. The primary objective is to compare the 6-month incidence of newly diagnosed AF between the two arms. Secondary endpoints include AF detection differences between risk groups, healthcare resource utilization per AF diagnosis, anticoagulation initiation rates, major clinical events (stroke, embolism, bleeding, mortality), and patient satisfaction. This study aims to demonstrate whether integrating AI-driven ECG risk stratification into routine care improves AF detection and optimizes healthcare resource use in real-world clinical practice.
Age range
30 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
New diagnosis of atrial fibrillation within 6 months. (confirmed by ECG, Holter, or patch ECG)
Timeframe: Baseline (randomization) to 6 months after enrollment. Event date is defined as the first ECG/Holter/patch ECG documenting AF during the 6-month follow-up.