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

NCT07173673 | Not Yet Recruiting

• 1 other identifier: 1-2024-0069
• Study Type: interventional
• Target: 1,230
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Usual Care (General Practice)

ACTIVE COMPARATOR

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

Other: Usual Care (General Practice)

AI-ECG Guided Care (SmartECG-AFrisk)

EXPERIMENTAL

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

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

Interventions

Usual Care (General Practice) OTHER

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.

Usual Care (General Practice)

AI-ECG Guided Care (SmartECG-AFrisk) DEVICE

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.

AI-ECG Guided Care (SmartECG-AFrisk)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hee Tae Yu, MD

CONTACT

+82-2-2228-8460; heetyu@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 15, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)