Evaluating the Accuracy and Practical Utility of AI-Enhanced 12-Lead ECG
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: AI-enhanced 12-lead ECG. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Toho Multicenter Registry for Evaluating the Accuracy and Practical Utility of AI-Enhanced 12-Lead ECG in Monitoring Atrial Fibrillation
Overview
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.
Primary outcome measures
- the 1-2-year composite endpoint of all-cause death and major adverse cardiac events (MACE), including AF recurrence [Time frame: one-two year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Japan · 1 center
- Toho University — Ōta-ku
Identifiers
NCT: NCT07316231 · T2025-051