A Retrospective, Single Center, Single Arm, Superiority Confirmatory Study to Evaluate the Clinical Validity of SMD-RVECG, Artificial Intelligence Software to Predict the Risk of Developing Atrial Fibrillation With Rapid Ventricular Response (AF With RVR) Within 2 Hours Using Single Lead-Based Electrocardiogram Analysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 348
- 主要终点
- AUROC of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response Within 2 Hours
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Electrocardiogram data meeting either of the following group definitions:
- •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
- •If the relevant episode 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 the episode, with a minimum electrocardiogram recording duration of 10 minutes
- •Other data considered suitable for the study by the principal investigator
排除标准
- •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
- •Electrocardiogram data from a participant whose baseline heart rate remained at 110 beats per minute or greater irrespective of atrial fibrillation
- •Data considered unsuitable for this clinical study by the principal investigator
结局指标
主要结局
AUROC of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response Within 2 Hours
时间窗: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 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.
次要结局
- Area Under the Precision-Recall Curve of SMD-RVECG(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(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(During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours)
- Positive Predictive Value of SMD-RVECG(During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours)
- Negative Predictive Value of SMD-RVECG(During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours)
- F1 Score of SMD-RVECG(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(Within the 2-hour period preceding the onset of atrial fibrillation with rapid ventricular response)