Clinical Validation of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response Within 2 Hours | NCT07722039

NCT07722039

Overview

NCT ID: NCT07722039
Lead Sponsor: HUINNO Co., LtdINDUSTRY
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
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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 23, 2026Actual
Start Date: Oct 1, 2026Estimated
Primary Completion Date: Nov 30, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 348Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: JooYeon YooContact
clinical_trial@huinno.com+82-2-2051-3161

Similar Studies

Participant Group/Arms

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