Clinical Validation of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours Usin… (NCT07722078) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Validation of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours Using Single-Lead ECG Data
797 participantsStarted 2026-10-01
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 recordi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AUROC of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours
Timeframe: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases (up to 2 hours)
2
AUROC of SMD-AFECG for Predicting Repeated Atrial Fibrillation Within 2 Hours
Timeframe: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases (up to 2 hours)