Atrial Fibrillation (AF)NCT07722078
Clinical Validation of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours Using Single-Lead ECG Data
An observational study of Atrial Fibrillation (AF) and Atrial Fibrillation New Onset, run by HUINNO Co., Ltd.
Trial summary
The purpose of this retrospective study is to evaluate the clinical performance of SMD-AFECG, an artificial intelligence-based medical device software that predicts the risk of atrial fibrillation occurring within 2 hours using single-lead electrocardiogram data. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Atrial Fibrillation New Onset
- How many people
- 797 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Dec 2026
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Retrospective, Single-Center, Single-Arm, Superiority Confirmatory Study to Evaluate the Clinical Validity of SMD-AFECG, Artificial Intelligence Software to Predict the Risk of Atrial Fibrillation, Including First Episode Within 2 Hours, Using Single-Lead-Based Electrocardiogram Analysis
The purpose of this retrospective study is to evaluate the clinical performance of SMD-AFECG, an artificial intelligence-based medical device software that predicts the risk of atrial fibrillation occurring within 2 hours using single-lead electrocardiogram data. A total of 797 eligible electrocardiogram datasets collected through VitalDB at Seoul National University Hospital will be included. The performance of SMD-AFECG will be evaluated separately for new-onset atrial fibrillation in patients without a previous history of atrial fibrillation (NOAF) and atrial fibrillation episodes in patients with a previous history of atrial fibrillation (RAF). Two physicians blinded to the software results will review the electrocardiogram data and relevant medical records to establish the reference-standard classification. The blinded electrocardiogram datasets will then be analyzed using SMD-AFECG, and the software-generated predictions will be compared with the reference standard to evaluate the area under the receiver operating characteristic curve for NOAF and RAF.
Read the detailed description
This clinical study is designed as a retrospective, single-center, single-arm, superiority confirmatory clinical performance study.
Pre-screening Electronic medical records and the VitalDB database at Seoul National University Hospital will be reviewed to identify potentially eligible data. The study will use continuous single-lead electrocardiogram data collected through VitalDB between September 1, 2022, and before September 30, 2025, from patients who were 19 years of age or older at the time of data collection.
Screening and Data Collection A screening number will be assigned sequentially to each potentially eligible case. Eligibility will be determined by reviewing the predefined inclusion and exclusion criteria. For eligible cases, continuous single-lead electrocardiogram data, signal loss, heart rate, the occurrence and timing of atrial fibrillation episodes, the electrocardiogram collection period, demographic information, previous history of atrial fibrillation, and pregnancy status will be collected. Directly identifying personal information will not be collected.
Test Dataset Creation Eligible data will be classified according to the presence or absence of a previous history of atrial fibrillation and the occurrence of an atrial fibrillation episode. The datasets will be categorized as new-onset atrial fibrillation positive or negative and repeated atrial fibrillation positive or negative. A subject number will then be assigned to each eligible dataset.
The planned sample size is 797 cases, including 462 cases for the evaluation of new-onset atrial fibrillation and 335 cases for the evaluation of repeated atrial fibrillation.
Reference Standard Establishment Two physicians with at least 5 years of relevant clinical experience will independently review the electrocardiogram data and relevant medical records. They will assess the suitability of the electrocardiogram data, confirm the presence or absence and timing of atrial fibrillation episodes, and verify the previous history of atrial fibrillation. Any disagreement between the physicians will be resolved according to the procedures specified in the study protocol. The final agreed classification will be used as the reference standard.
Application of the Investigational Device The medical device operator will receive the test electrocardiogram datasets labeled only with screening numbers and will not be provided with the reference-standard results or positive or negative group classifications. The blinded datasets will be analyzed using SMD-AFECG to generate the predicted risk of atrial fibrillation occurring within 2 hours. The software-generated results will be recorded in the electronic data capture system.
Statistical Analysis The software-generated predictions will be compared with the reference-standard classifications. The primary performance measures are the areas under the receiver operating characteristic curves for the prediction of new-onset atrial fibrillation and repeated atrial fibrillation. Two-sided 95% confidence intervals will be calculated using DeLong's method with a Wald-type confidence interval.
The performance criterion for new-onset atrial fibrillation will be met if the lower bound of the 95% confidence interval for the area under the curve is greater than 0.7753. The performance criterion for repeated atrial fibrillation will be met if the corresponding lower bound is greater than 0.8299. The study will be considered successful only if both primary performance criteria are met.
Secondary performance measures include the area under the precision-recall curve, precision, recall, F1 score, sensitivity, specificity, positive predictive value, negative predictive value, confusion-matrix results at different thresholds, and prediction time horizon.
Because this is a retrospective study using previously collected data, there will be no direct participant contact, additional examination, treatment, or change in clinical care.
- Keywords
- New-Onset Atrial Fibrillation, Recurrent Atrial Fibrillation, Atrial Fibrillation Prediction, Single-Lead Electrocardiogram, Artificial Intelligence, Software as a Medical Device, SMD-AFECG, Repeated Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NOAF Positive Group | Single-lead electrocardiogram datasets from patients without a previous history of atrial fibrillation that include the first atrial fibrillation episode. The datasets include an atrial fibrillation-free electrocardiogram period before the onset of atrial fibrillation and electrocardiogram data following its onset. SMD-AFECG will be retrospectively applied to estimate the risk of atrial fibrillation occurring within 2 hours. | |
| NOAF Negative Group | Single-lead electrocardiogram datasets from patients without a previous history of atrial fibrillation and without an atrial fibrillation episode during the predefined assessment period. The datasets include a continuous atrial fibrillation-free electrocardiogram period before a selected index time and electrocardiogram data following the index time. SMD-AFECG will be retrospectively applied to estimate the risk of atrial fibrillation occurring within 2 hours. | |
| RAF Positive Group | Single-lead electrocardiogram datasets from patients with a previous history of atrial fibrillation that include an atrial fibrillation episode. The datasets include an atrial fibrillation-free electrocardiogram period before the onset of atrial fibrillation and electrocardiogram data following its onset. SMD-AFECG will be retrospectively applied to estimate the risk of atrial fibrillation occurring within 2 hours. | |
| RAF Negative Group | Single-lead electrocardiogram datasets from patients with a previous history of atrial fibrillation and without an atrial fibrillation episode during the predefined assessment period. The datasets include a continuous atrial fibrillation-free electrocardiogram period before a selected index time and electrocardiogram data following the index time. SMD-AFECG will be retrospectively applied to estimate the risk of atrial fibrillation occurring within 2 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUROC of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours
The area under the receiver operating characteristic curve (AUROC) will be calculated by comparing the maximum risk score generated by SMD-AFECG with the reference-standard classification of the NOAF-positive and NOAF-negative ECG datasets. A two-sided 95% confidence interval will be estimated using DeLong's method with a Wald-type confidence interval. The performance criterion will be met if the lower bound of the 95% confidence interval is greater than 0.7753.
Measured: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases (up to 2 hours)
AUROC of SMD-AFECG for Predicting Repeated Atrial Fibrillation Within 2 Hours
The area under the receiver operating characteristic curve (AUROC) will be calculated by comparing the maximum risk score generated by SMD-AFECG with the reference-standard classification of the RAF-positive and RAF-negative ECG datasets. A two-sided 95% confidence interval will be estimated using DeLong's method with a Wald-type confidence interval. The performance criterion will be met if the lower bound of the 95% confidence interval is greater than 0.8299.
Measured: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases (up to 2 hours)
Secondary outcomes (14)
AUPRC of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours
The area under the precision-recall curve (AUPRC) will be calculated from the relationship between precision and recall using the reference-standard NOAF-positive and NOAF-negative ECG datasets. AUPRC ranges from 0 to 1, with higher values indicating better identification of positive cases.
Measured: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
AUPRC of SMD-AFECG for Predicting Repeated Atrial Fibrillation Within 2 Hours
The area under the precision-recall curve (AUPRC) will be calculated from the relationship between precision and recall using the reference-standard RAF-positive and RAF-negative ECG datasets. AUPRC ranges from 0 to 1, with higher values indicating better identification of positive cases.
Measured: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
Threshold-Specific Sensitivity of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours
At each evaluated threshold, sensitivity, also referred to as recall, will be calculated as the proportion of reference-standard NOAF-positive ECG datasets classified as positive by SMD-AFECG.
Measured: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
Threshold-Specific Sensitivity of SMD-AFECG for Predicting Repeated Atrial Fibrillation Within 2 Hours
At each evaluated threshold, sensitivity, also referred to as recall, will be calculated as the proportion of reference-standard RAF-positive ECG datasets classified as positive by SMD-AFECG.
Measured: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
Threshold-Specific Specificity of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours
At each evaluated threshold, specificity will be calculated as the proportion of reference-standard NOAF-negative ECG datasets classified as negative by SMD-AFECG.
Measured: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
Threshold-Specific Specificity of SMD-AFECG for Predicting Repeated Atrial Fibrillation Within 2 Hours
At each evaluated threshold, specificity will be calculated as the proportion of reference-standard RAF-negative ECG datasets classified as negative by SMD-AFECG.
Measured: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
Threshold-Specific Positive Predictive Value of SMD-AFECG for New-Onset Atrial Fibrillation
At each evaluated threshold, positive predictive value, also referred to as precision, will be calculated as the proportion of ECG datasets classified as positive by SMD-AFECG that are NOAF-positive according to the reference standard.
Measured: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
Threshold-Specific Positive Predictive Value of SMD-AFECG for Repeated Atrial Fibrillation
At each evaluated threshold, positive predictive value, also referred to as precision, will be calculated as the proportion of ECG datasets classified as positive by SMD-AFECG that are RAF-positive according to the reference standard.
Measured: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
Threshold-Specific Negative Predictive Value of SMD-AFECG for New-Onset Atrial Fibrillation
At each evaluated threshold, negative predictive value will be calculated as the proportion of ECG datasets classified as negative by SMD-AFECG that are NOAF-negative according to the reference standard.
Measured: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
Threshold-Specific Negative Predictive Value of SMD-AFECG for Repeated Atrial Fibrillation
At each evaluated threshold, negative predictive value will be calculated as the proportion of ECG datasets classified as negative by SMD-AFECG that are RAF-negative according to the reference standard.
Measured: At each evaluated threshold, negative predictive value will be calculated as the proportion of ECG datasets classified as negative by SMD-AFECG that are RAF-negative according to the reference standard.
Threshold-Specific F1 Score of SMD-AFECG for Predicting New-Onset Atrial Fibrillation
At each evaluated threshold, the F1 score will be calculated as the harmonic mean of precision and recall for the classification of NOAF-positive and NOAF-negative ECG datasets. Values range from 0 to 1, with higher values indicating better performance.
Measured: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
Threshold-Specific F1 Score of SMD-AFECG for Predicting Repeated Atrial Fibrillation
At each evaluated threshold, the F1 score will be calculated as the harmonic mean of precision and recall for the classification of RAF-positive and RAF-negative ECG datasets. Values range from 0 to 1, with higher values indicating better performance.
Measured: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
Prediction Time Horizon of SMD-AFECG for New-Onset Atrial Fibrillation
The prediction time horizon will be calculated as the time interval, in minutes, between the SMD-AFECG prediction or alarm and the onset of the reference-standard first atrial fibrillation episode among NOAF-positive ECG datasets.
Measured: Within the 2-hour period before the onset of the first atrial fibrillation episode
Prediction Time Horizon of SMD-AFECG for Repeated Atrial Fibrillation
The prediction time horizon will be calculated as the time interval, in minutes, between the SMD-AFECG prediction or alarm and the onset of the reference-standard atrial fibrillation episode among RAF-positive ECG datasets.
Measured: Within the 2-hour period before the onset of the atrial fibrillation episode
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 797 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HUINNO Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital, Korea Medical Device Development Fund
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722078
- Sponsor's protocol ID
- HU-NOAF-01
- Other IDs
- RS-2026-25543193
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No: Individual participant data collected in this study are not planned to be shared with external researchers. Any future sharing would require separate sponsor approval and compliance with applicable privacy, ethical, and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Single-Center, Single-Arm, Superiority Confirmatory Study to Evaluate the Clinical Validity of SMD-AFECG, Artificial Intelligence Software to Predict the Risk of Atrial Fibrillation, Including First Episode Within 2 Hours, Using Single-Lead-Based Electrocardiogram Analysis
- ClinicalTrials.gov ID
- NCT07722078
- Acronym / sponsor ID
- HU-NOAF-01
- Keywords
- New-Onset Atrial Fibrillation, Recurrent Atrial Fibrillation, Atrial Fibrillation Prediction, Single-Lead Electrocardiogram, Artificial Intelligence, Software as a Medical Device, SMD-AFECG, Repeated Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 797 participants (estimated)
- Lead sponsor
- HUINNO Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital, Korea Medical Device Development Fund
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jul 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.
The purpose of this retrospective study is to evaluate the clinical performance of SMD-AFECG, an artificial intelligence-based medical device software that predicts the risk of atrial fibrillation occurring within 2 hours using single-lead electrocardiogram data. A total of 797 eligible electrocardiogram datasets collected through VitalDB at Seoul National University Hospital will be included. The performance of SMD-AFECG will be evaluated separately for new-onset atrial fibrillation in patients without a previous history of atrial fibrillation (NOAF) and atrial fibrillation episodes in patients with a previous history of atrial fibrillation (RAF). Two physicians blinded to the software results will review the electrocardiogram data and relevant medical records to establish the reference-standard classification. The blinded electrocardiogram datasets will then be analyzed using SMD-AFECG, and the software-generated predictions will be compared with the reference standard to evaluate the area under the receiver operating characteristic curve for NOAF and RAF.
Detailed description
This clinical study is designed as a retrospective, single-center, single-arm, superiority confirmatory clinical performance study.
Pre-screening Electronic medical records and the VitalDB database at Seoul National University Hospital will be reviewed to identify potentially eligible data. The study will use continuous single-lead electrocardiogram data collected through VitalDB between September 1, 2022, and before September 30, 2025, from patients who were 19 years of age or older at the time of data collection.
Screening and Data Collection A screening number will be assigned sequentially to each potentially eligible case. Eligibility will be determined by reviewing the predefined inclusion and exclusion criteria. For eligible cases, continuous single-lead electrocardiogram data, signal loss, heart rate, the occurrence and timing of atrial fibrillation episodes, the electrocardiogram collection period, demographic information, previous history of atrial fibrillation, and pregnancy status will be collected. Directly identifying personal information will not be collected.
Test Dataset Creation Eligible data will be classified according to the presence or absence of a previous history of atrial fibrillation and the occurrence of an atrial fibrillation episode. The datasets will be categorized as new-onset atrial fibrillation positive or negative and repeated atrial fibrillation positive or negative. A subject number will then be assigned to each eligible dataset.
The planned sample size is 797 cases, including 462 cases for the evaluation of new-onset atrial fibrillation and 335 cases for the evaluation of repeated atrial fibrillation.
Reference Standard Establishment Two physicians with at least 5 years of relevant clinical experience will independently review the electrocardiogram data and relevant medical records. They will assess the suitability of the electrocardiogram data, confirm the presence or absence and timing of atrial fibrillation episodes, and verify the previous history of atrial fibrillation. Any disagreement between the physicians will be resolved according to the procedures specified in the study protocol. The final agreed classification will be used as the reference standard.
Application of the Investigational Device The medical device operator will receive the test electrocardiogram datasets labeled only with screening numbers and will not be provided with the reference-standard results or positive or negative group classifications. The blinded datasets will be analyzed using SMD-AFECG to generate the predicted risk of atrial fibrillation occurring within 2 hours. The software-generated results will be recorded in the electronic data capture system.
Statistical Analysis The software-generated predictions will be compared with the reference-standard classifications. The primary performance measures are the areas under the receiver operating characteristic curves for the prediction of new-onset atrial fibrillation and repeated atrial fibrillation. Two-sided 95% confidence intervals will be calculated using DeLong's method with a Wald-type confidence interval.
The performance criterion for new-onset atrial fibrillation will be met if the lower bound of the 95% confidence interval for the area under the curve is greater than 0.7753. The performance criterion for repeated atrial fibrillation will be met if the corresponding lower bound is greater than 0.8299. The study will be considered successful only if both primary performance criteria are met.
Secondary performance measures include the area under the precision-recall curve, precision, recall, F1 score, sensitivity, specificity, positive predictive value, negative predictive value, confusion-matrix results at different thresholds, and prediction time horizon.
Because this is a retrospective study using previously collected data, there will be no direct participant contact, additional examination, treatment, or change in clinical care.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NOAF Positive Group | – | –Single-lead electrocardiogram datasets from patients without a previous history of atrial fibrillation that include the first atrial fibrillation episode. The datasets include an atrial fibrillation-free electrocardiogram period before the onset of atrial fibrillation and electrocardiogram data following its onset. SMD-AFECG will be retrospectively applied to estimate the risk of atrial fibrillation occurring within 2 hours. |
| NOAF Negative Group | – | –Single-lead electrocardiogram datasets from patients without a previous history of atrial fibrillation and without an atrial fibrillation episode during the predefined assessment period. The datasets include a continuous atrial fibrillation-free electrocardiogram period before a selected index time and electrocardiogram data following the index time. SMD-AFECG will be retrospectively applied to estimate the risk of atrial fibrillation occurring within 2 hours. |
| RAF Positive Group | – | –Single-lead electrocardiogram datasets from patients with a previous history of atrial fibrillation that include an atrial fibrillation episode. The datasets include an atrial fibrillation-free electrocardiogram period before the onset of atrial fibrillation and electrocardiogram data following its onset. SMD-AFECG will be retrospectively applied to estimate the risk of atrial fibrillation occurring within 2 hours. |
| RAF Negative Group | – | –Single-lead electrocardiogram datasets from patients with a previous history of atrial fibrillation and without an atrial fibrillation episode during the predefined assessment period. The datasets include a continuous atrial fibrillation-free electrocardiogram period before a selected index time and electrocardiogram data following the index time. SMD-AFECG will be retrospectively applied to estimate the risk of atrial fibrillation occurring within 2 hours. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (6 listed)
- 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
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
AUROC of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours
Time frame: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases (up to 2 hours)
The area under the receiver operating characteristic curve (AUROC) will be calculated by comparing the maximum risk score generated by SMD-AFECG with the reference-standard classification of the NOAF-positive and NOAF-negative ECG datasets. A two-sided 95% confidence interval will be estimated using DeLong's method with a Wald-type confidence interval. The performance criterion will be met if the lower bound of the 95% confidence interval is greater than 0.7753.
AUROC of SMD-AFECG for Predicting Repeated Atrial Fibrillation Within 2 Hours
Time frame: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases (up to 2 hours)
The area under the receiver operating characteristic curve (AUROC) will be calculated by comparing the maximum risk score generated by SMD-AFECG with the reference-standard classification of the RAF-positive and RAF-negative ECG datasets. A two-sided 95% confidence interval will be estimated using DeLong's method with a Wald-type confidence interval. The performance criterion will be met if the lower bound of the 95% confidence interval is greater than 0.8299.
14 secondary outcomes
AUPRC of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours
Time frame: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
AUPRC of SMD-AFECG for Predicting Repeated Atrial Fibrillation Within 2 Hours
Time frame: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
Threshold-Specific Sensitivity of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours
Time frame: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
Threshold-Specific Sensitivity of SMD-AFECG for Predicting Repeated Atrial Fibrillation Within 2 Hours
Time frame: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
Threshold-Specific Specificity of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours
Time frame: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
Threshold-Specific Specificity of SMD-AFECG for Predicting Repeated Atrial Fibrillation Within 2 Hours
Time frame: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
Threshold-Specific Positive Predictive Value of SMD-AFECG for New-Onset Atrial Fibrillation
Time frame: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
Threshold-Specific Positive Predictive Value of SMD-AFECG for Repeated Atrial Fibrillation
Time frame: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
Threshold-Specific Negative Predictive Value of SMD-AFECG for New-Onset Atrial Fibrillation
Time frame: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
Threshold-Specific Negative Predictive Value of SMD-AFECG for Repeated Atrial Fibrillation
Time frame: At each evaluated threshold, negative predictive value will be calculated as the proportion of ECG datasets classified as negative by SMD-AFECG that are RAF-negative according to the reference standard.
Threshold-Specific F1 Score of SMD-AFECG for Predicting New-Onset Atrial Fibrillation
Time frame: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
Threshold-Specific F1 Score of SMD-AFECG for Predicting Repeated Atrial Fibrillation
Time frame: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases, up to 2 hours
Prediction Time Horizon of SMD-AFECG for New-Onset Atrial Fibrillation
Time frame: Within the 2-hour period before the onset of the first atrial fibrillation episode
Prediction Time Horizon of SMD-AFECG for Repeated Atrial Fibrillation
Time frame: Within the 2-hour period before the onset of the atrial fibrillation episode
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 23 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data collected in this study are not planned to be shared with external researchers. Any future sharing would require separate sponsor approval and compliance with applicable privacy, ethical, and institutional requirements.
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Atrial Fibrillation (AF)
Active, not recruitingObservational study
Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Major Gastrointestinal Bleeding (MGIB)
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF) and Atrial Fibrillation New Onset, run by HUINNO Co., Ltd.
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 8 inclusion and 6 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: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact JooYeon Yoo (+82-2-2051-3161, clinical_trial@huinno.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUROC of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours (time frame: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases (up to 2 hours)). The study lists 2 primary outcomes in all. 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 23 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.