AI reads Single-Lead ECG to predict AFib with rapid heart rate within two hours
NCT ID NCT07722039
First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This study tests whether an artificial intelligence software called SMD-RVECG can predict the risk of atrial fibrillation with rapid ventricular response (a fast, irregular heart rhythm) within the next two hours. Researchers will analyze 348 existing single-lead electrocardiogram recordings from a hospital database. The AI's predictions will be compared to a reference standard set by two doctors to see how accurate it is.
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-RVECG that analyzes single-lead electrocardiogram data
- What this could lead to
- If it works, this AI could help doctors quickly identify patients at risk of a dangerous heart rhythm episode, enabling earlier intervention.
- What could go wrong
- This is a retrospective study using existing data, not a real-time test. The AI may not perform as well in live clinical settings or on different patient populations.
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
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About 348 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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 between September 1, 2022, and September 30, 2025. The study population includes patients with atrial fibrillation whose eligible electrocardiogram datasets are classified according to the presence or absence of rapid ventricular response. AF with RVR-positive datasets include atrial fibrillation followed by rapid ventricular response, defined as an average heart rate of 110 beats per minute or greater for at least 30 seconds. AF with RVR-negative datasets include atrial fibrillation without rapid ventricular response during the predefined assessment period.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Continuous single-lead electrocardiogram data collected through VitalDB at Seoul National University Hospital between September 1, 2022, and September 30, 2025 * Participant aged 19 years or older at the time of electrocardiogram data collection * Electrocardiogram data meeting either of the following group definitions: * AF with RVR-positive group: atrial fibrillation followed by rapid ventricular response, defined as an average heart rate of 110 beats per minute or greater for at least 30 seconds, with available electrocardiogram data for up to 2 hours before the onset of rapid ventricular response and after the onset in accordance with the protocol * AF with RVR-negative group: atrial fibrillation without rapid ventricular response, with 3 hours of electrocardiogram data available before a selected index time corresponding to a similar time during hospitalization as that used for positive cases * If the relevant episode 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 the episode, with a minimum electrocardiogram recording duration of 10 minutes * Other data considered suitable for the study by the principal investigator 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 * Electrocardiogram data from a participant whose baseline heart rate remained at 110 beats per minute or greater irrespective of atrial fibrillation * Data considered unsuitable for this clinical study by the principal investigator
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Study contacts
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Contact
Email: •••••@•••••
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