AI-enhanced 12-lead ECG to reveal hidden atrial fibrillation risk
Toho Multicenter Registry for Evaluating the Accuracy and Practical Utility of AI-Enhanced 12-Lead ECG in Monitoring Atrial Fibrillation
This project will test whether an AI-enhanced 12-lead ECG can detect hidden or future atrial fibrillation risk in adults who are in sinus rhythm.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Toho University Academic / other |
| Locations | 1 site (Ōta-ku, Tokyo) |
| Trial ID | NCT07316231 on ClinicalTrials.gov |
What this trial studies
This observational study applies an AI algorithm to standard 12-lead ECGs that classifies sinus-rhythm traces into four risk categories for prior AF. Adults with AF/AT who are in or can be confirmed in sinus rhythm at the time of ECG will be enrolled and followed for subsequent AF events and clinical outcomes. The study will compare AI risk categories with later documented AF episodes, routine clinical data, and outcomes such as stroke or heart failure to measure diagnostic accuracy and clinical usefulness. The aim is to clarify how well the tool predicts incident or previously undetected AF and whether it can inform monitoring and treatment timing.
Who should consider this trial
Good fit: Adults (≥18) with paroxysmal or suspected AF/AT who are in sinus rhythm at the time of ECG recording and have a clinical reason to suspect AF are the ideal candidates.
Not a fit: Patients with long-standing persistent or permanent AF, frequent premature beats that prevent acquiring a sinus-rhythm ECG, or no clinical indication to suspect AF are unlikely to benefit.
Why it matters
Potential benefit: If accurate, the tool could help identify patients who need closer monitoring or earlier treatment to reduce the risk of stroke and heart failure.
How similar studies have performed: Previous studies using AI on sinus-rhythm ECGs have shown promising ability to predict occult or future AF, but broader real-world validation is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Age ≥18 years 2. 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 1. Age \<18 years 2. History of long-standing persistent or permanent atrial fibrillation 3. Frequent premature beats preventing acquisition of a sinus rhythm ECG 4. Patients with no clinical indication to suspect atrial fibrillation
Where this trial is running
Ōta-ku, Tokyo
- Toho University — Ōta-ku, Tokyo, Japan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.