Clinical Trial

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

Study acronym: AFRVR
Not Yet Recruiting
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.
Trial Details
NCT Number NCT07722039
Lead Sponsor HUINNO Co., Ltd
Collaborators: Seoul National University Hospital, Korea Medical Device Development Fund
Conditions Atrial Fibrillation (AF), Atrial Fibrillation With Rapid Ventricular Response
Enrollment 348 participants
Start Date 2026-10-01
Primary Completion 2026-11-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-23