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NCT07722039

Clinical Validation of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response Within 2 Hours

Sponsor: HUINNO Co., Ltd

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

OBSERVATIONAL

Enrollment

348

Start Date

2026-10-01

Completion Date

2026-12-31

Last Updated

2026-07-23

Healthy Volunteers

Conditions

Atrial Fibrillation (AF)Atrial Fibrillation With Rapid Ventricular Response

Interventions

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.

Inclusion Criteria: * 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 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 * 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