Clinical Validation of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours Using Single-Lead ECG Data | NCT07722078

NCT07722078

Overview

NCT ID: NCT07722078
Lead Sponsor: HUINNO Co., LtdINDUSTRY
Official Title: A Retrospective, Single-Center, Single-Arm, Superiority Confirmatory Study to Evaluate the Clinical Validity of SMD-AFECG, Artificial Intelligence Software to Predict the Risk of Atrial Fibrillation, Including First Episode 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-AFECG, an artificial intelligence-based medical device software that predicts the risk of atrial fibrillation occurring within 2 hours using single-lead electrocardiogram data. A total of 797 eligible electrocardiogram datasets collected through VitalDB at Seoul National University Hospital will be included. The performance of SMD-AFECG will be evaluated separately for new-onset atrial fibrillation in patients without a previous history of atrial fibrillation (NOAF) and atrial fibrillation episodes in patients with a previous history of atrial fibrillation (RAF). Two 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-AFECG, and the software-generated predictions will be compared with the reference standard to evaluate the area under the receiver operating characteristic curve for NOAF and RAF.

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:

Existing continuous single-lead electrocardiogram data collected through VitalDB at Seoul National University Hospital from September 1, 2022, to before September 30, 2025

Participant aged 19 years or older at the time of electrocardiogram data collection

Availability of an electrocardiogram dataset meeting one of the following criteria:

No previous history of atrial fibrillation and a first atrial fibrillation episode, with continuous atrial fibrillation-free electrocardiogram data for the 2 hours before onset and electrocardiogram data for 1 hour after onset (NOAF-positive group)

No previous history of atrial fibrillation and no atrial fibrillation episode, with continuous atrial fibrillation-free electrocardiogram data for the 2 hours before a selected index time and electrocardiogram data for 1 hour after the index time (NOAF-negative group)

Previous history of atrial fibrillation and an atrial fibrillation episode, with continuous atrial fibrillation-free electrocardiogram data for the 2 hours before onset and electrocardiogram data for 1 hour after onset (RAF-positive group)

Previous history of atrial fibrillation and no atrial fibrillation episode, with continuous atrial fibrillation-free electrocardiogram data for the 2 hours before a selected index time and electrocardiogram data for 1 hour after the index time (RAF-negative group)

If atrial fibrillation 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 atrial fibrillation onset, with a minimum recorded electrocardiogram duration of 10 minutes

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

Data considered unsuitable for this clinical study by the principal investigator

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 797Estimated
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

NOAF Positive Group

Single-lead electrocardiogram datasets from patients without a previous history of atrial fibrillation that include the first atrial fibrillation episode. The datasets include an atrial fibrillation-free electrocardiogram period before the onset of atrial fibrillation and electrocardiogram data following its onset. SMD-AFECG will be retrospectively applied to estimate the risk of atrial fibrillation occurring within 2 hours.

NOAF Negative Group

Single-lead electrocardiogram datasets from patients without a previous history of atrial fibrillation and without an atrial fibrillation episode during the predefined assessment period. The datasets include a continuous atrial fibrillation-free electrocardiogram period before a selected index time and electrocardiogram data following the index time. SMD-AFECG will be retrospectively applied to estimate the risk of atrial fibrillation occurring within 2 hours.

RAF Positive Group

Single-lead electrocardiogram datasets from patients with a previous history of atrial fibrillation that include an atrial fibrillation episode. The datasets include an atrial fibrillation-free electrocardiogram period before the onset of atrial fibrillation and electrocardiogram data following its onset. SMD-AFECG will be retrospectively applied to estimate the risk of atrial fibrillation occurring within 2 hours.

RAF Negative Group

Single-lead electrocardiogram datasets from patients with a previous history of atrial fibrillation and without an atrial fibrillation episode during the predefined assessment period. The datasets include a continuous atrial fibrillation-free electrocardiogram period before a selected index time and electrocardiogram data following the index time. SMD-AFECG will be retrospectively applied to estimate the risk of atrial fibrillation occurring within 2 hours.