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Can an AI spot a heart rhythm disorder two hours before it happens?

NCT ID NCT07722078

Diagnosis Sponsor: HUINNO Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This study tests whether an artificial intelligence software, SMD-AFECG, can predict the risk of atrial fibrillation (AF) within the next two hours using data from a single-lead electrocardiogram (ECG). Researchers will analyze nearly 800 ECG recordings from a hospital database, comparing the AI's predictions against expert review. The goal is to see if the software can reliably detect both first-time and repeat AF episodes, potentially enabling earlier warning and treatment.

What this could mean

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

Active substance
an artificial intelligence software called SMD-AFECG that analyzes single-lead electrocardiogram data
What this could lead to
If accurate, this AI could help doctors quickly identify patients at risk of atrial fibrillation, enabling earlier intervention and potentially preventing strokes.
What could go wrong
This is a retrospective study using existing data, not a real-time test. The AI's performance in a live clinical setting may differ, and false alarms or missed cases remain possible.

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 797 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Patients aged 19 years or older whose continuous single-lead electrocardiogram data were collected through VitalDB at Seoul National University Hospital from September 1, 2022, to before September 30, 2025. Eligible datasets will be identified retrospectively from the VitalDB registry and corresponding clinical records. The study population includes patients with and without a previous history of atrial fibrillation and with or without an atrial fibrillation episode during the predefined assessment window. Eligible datasets will be classified into the NOAF-positive, NOAF-negative, RAF-positive, and RAF-negative groups.

Ages

19 years and older

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: * Existing continuous single-lead electrocardiogram data collected through VitalDB at Seoul National University Hospital from September 1, 2022, to before September 30, 2025 * Participant aged 19 years or older at the time of electrocardiogram data collection * Availability of an electrocardiogram dataset meeting one of the following criteria: * No previous history of atrial fibrillation and a first atrial fibrillation episode, with continuous atrial fibrillation-free electrocardiogram data for the 2 hours before onset and electrocardiogram data for 1 hour after onset (NOAF-positive group) * No previous history of atrial fibrillation and no atrial fibrillation episode, with continuous atrial fibrillation-free electrocardiogram data for the 2 hours before a selected index time and electrocardiogram data for 1 hour after the index time (NOAF-negative group) * Previous history of atrial fibrillation and an atrial fibrillation episode, with continuous atrial fibrillation-free electrocardiogram data for the 2 hours before onset and electrocardiogram data for 1 hour after onset (RAF-positive group) * Previous history of atrial fibrillation and no atrial fibrillation episode, with continuous atrial fibrillation-free electrocardiogram data for the 2 hours before a selected index time and electrocardiogram data for 1 hour after the index time (RAF-negative group) * If atrial fibrillation occurred within 2 hours after the start of electrocardiogram recording, availability of electrocardiogram data from the start of recording through up to 1 hour after atrial fibrillation onset, with a minimum recorded electrocardiogram duration of 10 minutes Exclusion Criteria: * Electrocardiogram data considered to be of inadequate quality because of noise, poor equipment handling, unclear signals, artifacts, or similar problems * Electrocardiogram data with signal loss of 5 percent or greater * Electrocardiogram data with a heart rate below 30 beats per minute or above 300 beats per minute * Data collected from a participant who was pregnant or breastfeeding at the time of data collection * Data previously used for training or validation of the artificial intelligence model * Data considered unsuitable for this clinical study by the principal investigator

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation (AF) Atrial fibrillation new onset

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  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

Study contacts

  • Contact

    Email: •••••@•••••

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