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AI ECG could spot hidden heart rhythm risk before it strikes

NCT ID NCT07316231

Diagnosis Sponsor: Toho University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether an AI-enhanced 12-lead ECG can better identify people at risk for atrial fibrillation (AF), a major cause of stroke and heart failure. Researchers will enroll 350 adults with AF or atrial tachycardia who are in normal rhythm at the time of ECG recording. The AI analyzes the ECG to estimate hidden AF risk, and the team will track patients for 1-2 years to see if the AI's predictions match actual heart events.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AI-enhanced 12-lead ECG
What this could lead to
If successful, this AI tool could help doctors detect hidden atrial fibrillation earlier, potentially preventing strokes and heart failure.
What could go wrong
This is an observational registry, not a treatment trial. The AI's accuracy in real-world settings is still unproven, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study will be conducted at 6 centers throughout Japan, with the goal of enrolling a total of approximately 300-350 cases.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atrial fibrillation atrial tachycardia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ai-enhanced 12-lead ecg

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Toho University

    RECRUITING

    Ōta-ku, Tokyo, 143-8540, Japan

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