Clinical Validation of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours Using Single-Lead ECG Data
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-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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
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)
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 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.
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
797 Participants
are grouped into 4 trial groupsGroup A: NOAF Positive Group
Group B: NOAF Negative Group
Group C: RAF Positive Group
Group D: RAF Negative Group
Trial outcomes
Primary outcomes
1
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.
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)2
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.
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)Secondary outcomes
1
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.
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 hours2
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.
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 hours3
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.
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 hours4
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.
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 hoursLocations
Sponsors and contacts
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HUINNO Co., Ltd
Lead sponsor
Seoul National University Hospital
Collaborator
Korea Medical Device Development Fund
Collaborator
Source ClinicalTrials.gov
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