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

Yonsei University

Status: Not yet enrolling

Conditions: Atrial Fibrillation

Treatments: Other: Usual Care (General Practice); Device: AI-ECG Guided Care (SmartECG-AFrisk)

Study type: Interventional

Funder types: Other

Identifiers

NCT07173673

1-2024-0069

Details and patient eligibility

About

"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.

Enrollment: 1,230 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,230 participants in 2 patient groups

Usual Care (General Practice)

Active Comparator group

Description:

Symptom-based evaluation by physicians, including 12-lead ECG, Holter monitoring, or patch ECG at least once within 6 months

Treatment:

Other: Usual Care (General Practice)

AI-ECG Guided Care (SmartECG-AFrisk)

Experimental group

Description:

Monitoring strategy determined by SmartECG-AFrisk risk score (≥50 = high-risk vs \<50 = low-risk).

Treatment:

Device: AI-ECG Guided Care (SmartECG-AFrisk)