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NCT Number: NCT07316231

Evaluating the Accuracy and Practical Utility of AI-Enhanced 12-Lead ECG

Atrial fibrillation (AF) is a major cause of heart failure and ischemic stroke, making early detection and intervention critically important. However, timely ECG recording during paroxysmal episodes is often difficult, leading to delayed diagnosis. Recently, an AI-enhanced 12-lead ECG equipped with a "hidden AF risk estimation" function has been introduced. This technology analyzes sinus rhythm ECGs and stratifies the likelihood of prior AF into four risk categories. Although this novel approach may facilitate earlier AF detection and optimize the timing of therapeutic intervention, its clinical accuracy and real-world utility remain insufficiently validated. Therefore, this multicenter study aims to evaluate the diagnostic performance and clinical usefulness of AI-based AF risk assessment and to clarify its association with subsequent AF incidence and patient outcomes.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Toho University

Ōta-ku, Tokyo, 143-8540, Japan

Location status: Recruiting

Location contact

Ethics Committee of the Toho University

CONTACT

[email protected]

81+3-5763-6534

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Patients with atrial fibrillation or atrial tachycardia (AF/AT) in whom sinus rhythm is maintained or can be confirmed at the time of ECG recording

Exclusion criteria

  • Age <18 years
  • History of long-standing persistent or permanent atrial fibrillation
  • Frequent premature beats preventing acquisition of a sinus rhythm ECG
  • Patients with no clinical indication to suspect atrial fibrillation

Treatment and study plan

Primary outcomes

  1. the 1-2-year composite endpoint of all-cause death and major adverse cardiac events (MACE), including AF recurrence

    Time frame: one-two year

Sponsors and collaborators

Lead sponsor

Toho University

Other

Registry information

Official study title

Toho Multicenter Registry for Evaluating the Accuracy and Practical Utility of AI-Enhanced 12-Lead ECG in Monitoring Atrial Fibrillation

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 5, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.