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

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT07173673
• Lead Sponsor: Yonsei University

Brief Summary

"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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-07
• Study First Submitted QC: 2025-09-07
• Last Update Submitted: 2025-09-07
• Study First Posted: 2025-09-15
• Last Update Posted: 2025-09-15
• Study Start: 2025-11-01
• Primary Completion: 2027-11-30
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1230

Inclusion Criteria

- Adults ≥30 years old

• - Symptoms suggestive of atrial fibrillation (palpitations, dizziness, syncope, dyspnea, chest discomfort)
• - No evidence of AF on baseline 12-lead ECG
• - No prior history of AF diagnosis

Exclusion Criteria

• - Prior diagnosis of atrial fibrillation
• - Life expectancy ≤ 1 year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
New diagnosis of atrial fibrillation within 6 months. (confirmed by ECG, Holter, or patch ECG)	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.

Trial Locations

Locations (1)

Yonsei University College of Medicine; 🇰🇷 Seoul, South Korea