Clinical Validation of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response Within 2 Hours
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorHUINNO Co., Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
SMD-RVECG
DeviceSMD-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.
Treatment groups
348 Participants
are divided into 2 treatment groupsGroup A: AF With RVR Positive Group1 intervention
Group B: AF With RVR Negative Group1 intervention
Trial outcomes
Primary outcomes
1
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 hoursSecondary outcomes
1
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 hours2
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 hours3
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 hours4
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 hoursLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
HUINNO Co., Ltd
Lead sponsor
Seoul National University Hospital
Collaborator
Korea Medical Device Development Fund
Collaborator
Source ClinicalTrials.gov
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