AI-enhanced 12-lead ECGNCT07316231
Evaluating the Accuracy and Practical Utility of AI-Enhanced 12-Lead ECG
An observational study of AI-enhanced 12-lead ECG, run by Toho University at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- AI-enhanced 12-lead ECG
- How many people
- 350 participants
- Where
- 1 siteJapan
- Study dates
- 11 Sep 2025to 31 Aug 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted at 6 centers throughout Japan, with the goal of enrolling a total of approximately 300-350 cases.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Toho University
Ōta-ku, Tokyo, 143-8540
Ethics Committee of the Toho University, 81+3-5763-6534, omori.rinri@ext.toho-u.ac.jp
About this study
Official title: Toho Multicenter Registry for Evaluating the Accuracy and Practical Utility of AI-Enhanced 12-Lead ECG in Monitoring Atrial Fibrillation
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.
- Conditions
- AI-enhanced 12-lead ECG
What is being measured
The primary outcome is the main question the study is designed to answer.
the 1-2-year composite endpoint of all-cause death and major adverse cardiac events (MACE), including AF recurrence
Measured: one-two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start11 Sep 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AI-enhanced 12-lead ECGStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Toho University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hideki Koike, Toho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316231
- Sponsor's protocol ID
- T2025-051
- Status last verified
- Jan 2026
- First submitted
- 20 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toho Multicenter Registry for Evaluating the Accuracy and Practical Utility of AI-Enhanced 12-Lead ECG in Monitoring Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07316231
- Acronym / sponsor ID
- T2025-051
- Conditions
- AI-enhanced 12-lead ECG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Toho UniversityUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted at 6 centers throughout Japan, with the goal of enrolling a total of approximately 300-350 cases.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the 1-2-year composite endpoint of all-cause death and major adverse cardiac events (MACE), including AF recurrence
Time frame: one-two year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AI-enhanced 12-lead ECG, run by Toho University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the 1-2-year composite endpoint of all-cause death and major adverse cardiac events (MACE), including AF recurrence (time frame: one-two year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.