NCT07722078Not yet recruiting
Clinical Validation of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours Using Single-Lead ECG Data
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
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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 (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 797 (estimated)
- First submitted
- 20 Jul 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- HUINNO Co., Ltd
- Diseases
- Atrial fibrillation
- NCT number
- NCT07722078
What you commit to
- Study type: Observational
- Planned participants: 797
- From 1 Oct 2026 to the primary completion date, 30 Nov 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Data previously used for training or validation of the artificial intelligence model
Other illness
- Electrocardiogram data with a heart rate below 30 beats per minute or above 300 beats per minute
Other
- 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
- Data collected from a participant who was pregnant or breastfeeding at the time of data collection
- Data considered unsuitable for this clinical study by the principal investigator
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.