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Evaluation of the diagnosis rate of atrial fibrillation compared to general treatment using artificial intelligence electrocardiogram (SmartECG-AFrisk) in patients with suspected atrial fibrillation

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0011240
Enrollment
1230
Registered
2025-12-03
Start date
2026-02-02
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Test group - AI-ECG based treatment group (Practice with SmartECG-AFrisk): Determining ECG monitoring strategy through risk classification based on SmartECG-AFrisk algorithm (AI score

Sponsors

Yonsei University Health System, Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Subjects who voluntarily agreed in writing to participate in this clinical study 2) adults over 30 years of age 3) A person without atrial fibrillation according to a standard 12-guided electrocardiogram 4) a person with atrial fibrillation-related symptoms *Symptoms associated with atrial fibrillation: Symptoms mentioned in the guidelines for atrial fibrillation, such as palpitations, dizziness, breathlessness, frustration, fainting, stroke/temporary ischemic attack (TIA), and systemic embolism. 5) A person who is in sinus rhythm without other arrhythmia that may affect the diagnosis of atrial fibrillation *Other arrhythmias include: Pacing rhythm, atrioventricular block (AV block), Pause, ventricular tachycardia (SVT), ventricular tachycardia (VT), etc.

Exclusion criteria

Exclusion criteria: 1) a patient previously diagnosed with atrial fibrillation 2) Life expectancy is less than one year

Design outcomes

Primary

MeasureTime frame
New diagnostic rates of atrial fibrillation (AF) within 6 months

Secondary

MeasureTime frame
Evaluate the difference in atrial fibrillation (AF) diagnosis rates between high-risk and low-risk groups within 6 months.

Countries

Korea, Republic of

Contacts

Public Contactheetae yu

Yonsei University Health System, Severance Hospital

heetyu@yuhs.ac+82-2-2228-8522

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026