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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 797
- Primary Endpoint
- AUROC of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours
Study Overview
Brief 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. 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
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
- •Data considered unsuitable for this clinical study by the principal investigator
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- AUPRC of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours(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(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(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(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(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(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(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(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(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.)
- Threshold-Specific F1 Score of SMD-AFECG for Predicting New-Onset Atrial Fibrillation(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(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(Within the 2-hour period before the onset of the first atrial fibrillation episode)
- Prediction Time Horizon of SMD-AFECG for Repeated Atrial Fibrillation(Within the 2-hour period before the onset of the atrial fibrillation episode)