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

NCT07722039 | Not Yet Recruiting

• 2 other identifiers: HU-AFRVR-01RS-2026-25543193
• Study Type: observational
• Target: 348
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atrial Fibrillation (AF); Atrial Fibrillation With Rapid Ventricular Response

Keywords

Atrial Fibrillation With Rapid Ventricular Response; AF With RVR; Rapid Ventricular Response; Atrial Fibrillation Prediction; Single-Lead Electrocardiogram; Artificial Intelligence; Software as a Medical Device; SMD-RVECG

Outcome Measures

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.

  During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours

Secondary Outcomes (7)

• 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

Study Arms (2)

AF With RVR Positive Group

Electrocardiogram datasets from patients with atrial fibrillation in which rapid ventricular response occurred. Rapid ventricular response is defined as an average heart rate of 110 beats per minute or greater for at least 30 seconds. The dataset includes electrocardiogram data preceding the first onset of rapid ventricular response and data following the episode in accordance with the protocol. These datasets will be retrospectively analyzed using SMD-RVECG.

Device: SMD-RVECG

AF With RVR Negative Group

Electrocardiogram datasets from patients with atrial fibrillation in which rapid ventricular response did not occur during the predefined assessment period. The dataset includes electrocardiogram data from the 3 hours preceding a selected index time corresponding to a similar time during hospitalization as the onset time used for positive cases. These datasets will be retrospectively analyzed using SMD-RVECG.

Device: SMD-RVECG

Interventions

SMD-RVECG DEVICE

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.

AF With RVR Negative Group; AF With RVR Positive Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HUINNO Co., Ltd: lead
• Seoul National University Hospital: collaborator
• Korea Medical Device Development Fund: collaborator

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

JooYeon Yoo

CONTACT

+82-2-2051-3161; clinical_trial@huinno.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share