An observational study in Atrial Fibrillation (AF) and Atrial Fibrillation With Rapid Ventricular Response, sponsored by HUINNO Co., Ltd. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by HUINNO Co., Ltd · Observational
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The purpose of this retrospective study is to evaluate the clinical performance of SMD-RVECG, an artificial intelligence-based medical device software that analyzes single-lead electrocardiogram data to predict the risk of atrial fibrillation with rapid ventricular response occurring within 2 hours.
A total of 348 eligible electrocardiogram datasets collected through VitalDB at Seoul National University Hospital will be included. Atrial fibrillation with rapid ventricular response is defined in this study as atrial fibrillation accompanied by an average heart rate of 110 beats per minute or greater for at least 30 seconds.
Eligible datasets will be classified as positive or negative for atrial fibrillation with rapid ventricular response. Two qualified 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-RVECG, and the software-generated predictions will be compared with the reference standard to evaluate clinical performance.
This clinical study is designed as a retrospective, single-center, single-arm, superiority confirmatory clinical performance study conducted at Seoul National University Hospital.
Pre-screening Electronic medical records and the VitalDB registry 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 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 dataset. 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 with rapid ventricular response episodes, the electrocardiogram data 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 electrocardiogram datasets will be classified into positive and negative groups for atrial fibrillation with rapid ventricular response.
The positive group will include electrocardiogram datasets in which atrial fibrillation is followed by rapid ventricular response, defined as an average heart rate of 110 beats per minute or greater for at least 30 seconds. The dataset will include electrocardiogram data preceding the onset of rapid ventricular response and data following the episode, as specified in the study protocol.
The negative group will include electrocardiogram datasets with atrial fibrillation that is not accompanied by rapid ventricular response during the predefined assessment period.
The planned study dataset consists of 348 cases, including 58 positive cases and 290 negative cases.
Reference Standard Establishment Two anesthesiology and pain medicine specialists with at least 5 years of relevant clinical experience in electrocardiogram-based arrhythmia interpretation will independently review the electrocardiogram data and relevant medical records. The reviewers will assess electrocardiogram data quality, confirm the presence or absence and timing of atrial fibrillation with rapid ventricular response, and establish the reference-standard classification.
The reviewers will be blinded to each other's initial assessments and to the results generated by SMD-RVECG. If the two reviewers disagree, the classification will be determined through consensus and the basis for the consensus will be documented. If consensus cannot be reached, the dataset will be excluded from the study.
Application of the Investigational Device The medical device operator will receive the test electrocardiogram datasets identified only by screening numbers and will be blinded to the positive or negative reference-standard classifications. The datasets will be retrospectively analyzed using SMD-RVECG to generate risk estimates for atrial fibrillation with rapid ventricular response occurring within 2 hours. The software-generated peak risk values and corresponding times will be recorded.
Statistical Analysis The software-generated predictions will be compared with the reference-standard classifications. The primary performance measure is the area under the receiver operating characteristic curve for predicting atrial fibrillation with rapid ventricular response within 2 hours. A two-sided 95% confidence interval will be calculated using Newcombe's Wald method. The study will be considered successful if the lower bound of the 95% confidence interval is greater than 0.8.
Secondary performance measures include the area under the precision-recall curve, threshold-specific precision, recall, F1 score, sensitivity, specificity, positive predictive value, negative predictive value, confusion-matrix results, and prediction time horizon.
Because this retrospective study uses previously collected data, there will be no direct participant contact, additional examination, treatment, or change in clinical care.
4,009 studies on the registry are indexed under Atrial Fibrillation; 960 are open to participants now.
This study's planned enrollment of 348 is above the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →HUINNO Co., Ltd is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Electrocardiogram data meeting either of the following group definitions:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Electrocardiogram datasets from patients with atrial fibrillation in which rapid ventricular response occurred. Rapid ventricular response is defined as an average heart rate of 110 beats per minute or greater for at least 30 seconds. The dataset includes electrocardiogram data preceding the first onset of rapid ventricular response and data following the episode in accordance with the protocol. These datasets will be retrospectively analyzed using SMD-RVECG.
Device: SMD-RVECG
Electrocardiogram datasets from patients with atrial fibrillation in which rapid ventricular response did not occur during the predefined assessment period. The dataset includes electrocardiogram data from the 3 hours preceding a selected index time corresponding to a similar time during hospitalization as the onset time used for positive cases. These datasets will be retrospectively analyzed using SMD-RVECG.
Device: SMD-RVECG
SMD-RVECG is an artificial intelligence-based software as a medical device designed to analyze continuous single-lead electrocardiogram data and estimate the risk of atrial fibrillation with rapid ventricular response occurring within 2 hours. The software generates a risk score ranging from 0 to 100 based on electrocardiogram signal characteristics. In this retrospective study, blinded electrocardiogram datasets identified only by screening numbers will be analyzed using SMD-RVECG. The software-generated risk scores, peak values, and corresponding times will be recorded and compared with the reference-standard classifications. The software will not be used to guide the clinical care of the patients whose data are included.
AUROC of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response Within 2 Hours
The area under the receiver operating characteristic curve (AUROC) will be calculated by comparing the maximum risk score generated by SMD-RVECG with the reference-standard classification of the AF with RVR-positive and AF with RVR-negative electrocardiogram datasets. Sensitivity and the false-positive rate will be calculated across the evaluated decision thresholds to construct the receiver operating characteristic curve. A two-sided 95% confidence interval will be estimated using Newcombe's Wald method. The performance criterion will be met if the lower bound of the 95% confidence interval is greater than 0.8.
Time frame: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours
Area Under the Precision-Recall Curve of SMD-RVECG
The area under the precision-recall curve (AUPRC) will be calculated using the risk scores generated by SMD-RVECG and the reference-standard classification of the AF with RVR-positive and AF with RVR-negative electrocardiogram datasets. A higher AUPRC indicates better discrimination of AF with RVR-positive datasets.
Time frame: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours
Sensitivity of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response
Sensitivity, also referred to as recall, will be calculated at the evaluated decision thresholds as the proportion of reference-standard AF with RVR-positive datasets that are classified as positive by SMD-RVECG.
Time frame: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours
Specificity of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response
Specificity will be calculated at the evaluated decision thresholds as the proportion of reference-standard AF with RVR-negative datasets that are classified as negative by SMD-RVECG.
Time frame: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours
Positive Predictive Value of SMD-RVECG
Positive predictive value, also referred to as precision, will be calculated at the evaluated decision thresholds as the proportion of datasets classified as positive by SMD-RVECG that are AF with RVR-positive according to the reference standard.
Time frame: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours
Negative Predictive Value of SMD-RVECG
Negative predictive value will be calculated at the evaluated decision thresholds as the proportion of datasets classified as negative by SMD-RVECG that are AF with RVR-negative according to the reference standard.
Time frame: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours
F1 Score of SMD-RVECG
The F1 score will be calculated at the evaluated decision thresholds as the harmonic mean of precision and recall. The F1 score ranges from 0 to 1, with higher values indicating a better balance between precision and recall.
Time frame: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours
Prediction Time Horizon of SMD-RVECG for Atrial Fibrillation With Rapid Ventricular Response
For AF with RVR-positive datasets, the prediction time horizon will be calculated as the time interval between the software-generated prediction or alarm and the reference-standard onset of the AF with RVR episode.
Time frame: Within the 2-hour period preceding the onset of atrial fibrillation with rapid ventricular response
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Nov 2026, 1 month later.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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