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

NANot yet recruitingINTERVENTIONAL
Enrollment

1,230

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

November 30, 2027

Study Completion Date

November 30, 2027

Conditions
Atrial Fibrillation
Interventions
OTHER

Usual Care (General Practice)

Participants receive routine care based on current clinical guidelines. Symptom-driven evaluation is performed by physicians, including at least one diagnostic test within 6 months such as a standard 12-lead ECG, Holter monitoring, or patch ECG. The choice and frequency of monitoring are determined by physician discretion, reflecting real-world practice patterns.

DEVICE

AI-ECG Guided Care (SmartECG-AFrisk)

Participants undergo SmartECG-AFrisk analysis of baseline 12-lead ECGs recorded in sinus rhythm. The algorithm calculates an atrial fibrillation risk score, classifying participants as high-risk (score ≥50) or low-risk (\<50). Monitoring strategies are adapted accordingly: high-risk participants undergo targeted and potentially repeated ECG monitoring using 12-lead ECG, Holter, or patch ECG, while low-risk participants follow standard guideline-based care.

Trial Locations (1)

Unknown

Yonsei University College of Medicine, Seoul

All Listed Sponsors
lead

Yonsei University

OTHER

NCT07173673 - 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 | Biotech Hunter | Biotech Hunter