[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648620":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":21,"locations":10,"responsibleParty":27,"collaborators":29,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":10,"eligibilityCriteria":42,"healthyVolunteers":38,"sex":43,"minAge":44,"maxAge":10,"enrollmentInfo":45,"targetDuration":10,"studyType":48,"phases":10,"briefSummary":49,"conditions":50,"keywords":53,"overallStatus":62,"whyStopped":10,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":10},{"fullName":5,"class":6},"HUINNO Co., Ltd","INDUSTRY",[8,12,15,18],{"label":9,"type":10,"description":11,"interventionNames":10},"NOAF Positive Group",null,"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.",{"label":13,"type":10,"description":14,"interventionNames":10},"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.",{"label":16,"type":10,"description":17,"interventionNames":10},"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.",{"label":19,"type":10,"description":20,"interventionNames":10},"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.",[22],{"name":23,"role":24,"phone":25,"phoneExt":10,"email":26},"JooYeon Yoo","CONTACT","+82-2-2051-3161","clinical_trial@huinno.com",{"type":28,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[30,33],{"name":31,"class":32},"Seoul National University Hospital","OTHER",{"name":34,"class":35},"Korea Medical Device Development Fund","UNKNOWN","100648620","clinical-validation-of-smd-afecg-for-predicting-new-onset-atrial-fibrillation-within-2-hours-using-single-lead-ecg-data-100648620",false,"NCT07722078","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","Inclusion Criteria:\n\n* Existing continuous single-lead electrocardiogram data collected through VitalDB at Seoul National University Hospital from September 1, 2022, to before September 30, 2025\n* Participant aged 19 years or older at the time of electrocardiogram data collection\n* Availability of an electrocardiogram dataset meeting one of the following criteria:\n\n  * 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)\n  * 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)\n  * 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)\n  * 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)\n* 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\n\nExclusion Criteria:\n\n* Electrocardiogram data considered to be of inadequate quality because of noise, poor equipment handling, unclear signals, artifacts, or similar problems\n* Electrocardiogram data with signal loss of 5 percent or greater\n* Electrocardiogram data with a heart rate below 30 beats per minute or above 300 beats per minute\n* Data collected from a participant who was pregnant or breastfeeding at the time of data collection\n* Data previously used for training or validation of the artificial intelligence model\n* Data considered unsuitable for this clinical study by the principal investigator","ALL","19 Years",{"count":46,"type":47},797,"ESTIMATED","OBSERVATIONAL","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.",[51,52],"Atrial Fibrillation (AF)","Atrial Fibrillation New Onset",[54,55,56,57,58,59,60,61],"New-Onset Atrial Fibrillation","Recurrent Atrial Fibrillation","Atrial Fibrillation Prediction","Single-Lead Electrocardiogram","Artificial Intelligence","Software as a Medical Device","SMD-AFECG","Repeated Atrial Fibrillation","NOT_YET_RECRUITING","2026-07-20",{"date":65,"type":66},"2026-07-23","ACTUAL",{"date":68,"type":47},"2026-10-01",{"date":70,"type":47},"2026-12-31",{"name":5,"class":6}]