A Prospective, Multi-center, Randomized Clinical Trial to Evaluate the Detection of Atrial Fibrillation Using Artificial Intelligence-Enhanced Electrocardiography (SmartECG-AFrisk) Compared With Usual Care in Patients With Suspected Atrial Fibrillation: DEEP-AF

Brief summary (registry, in English)

"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.

What you commit to

• Study type: Interventional
• Planned participants: 1230
• From Nov 2025 to the primary completion date, 30 Nov 2027
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 30 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Related publications

• A multicenter randomized controlled study to evaluate the efficacy of an artificial intelligence-based electrocardiography for the detection of atrial fibrillation in patients with suspected symptoms (DEEP-AF).Heart Rhythm O2 · 2026 · PMID 42936621