[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"HUINNO Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":99},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"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":19,"type":20},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.",[24,25],"Atrial Fibrillation (AF)","Atrial Fibrillation New Onset",[27,28,29,30,31,32,33,34],"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":38,"type":39},"2026-07-23","ACTUAL",{"date":41,"type":20},"2026-10-01",{"date":43,"type":20},"2026-12-31",{"name":45,"class":46},"HUINNO Co., Ltd","INDUSTRY",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":66,"leadSponsor":67,"locationsCount":4},"100648534","clinical-validation-of-smd-rvecg-for-predicting-atrial-fibrillation-with-rapid-ventricular-response-within-2-hours-100648534","NCT07722039","Clinical Validation of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response Within 2 Hours","A Retrospective, Single Center, Single Arm, Superiority Confirmatory Study to Evaluate the Clinical Validity of SMD-RVECG, Artificial Intelligence Software to Predict the Risk of Developing Atrial Fibrillation With Rapid Ventricular Response (AF With RVR) Within 2 Hours Using Single Lead-Based Electrocardiogram Analysis","AFRVR","Inclusion Criteria:\n\n* Continuous single-lead electrocardiogram data collected through VitalDB at Seoul National University Hospital between September 1, 2022, and September 30, 2025\n* Participant aged 19 years or older at the time of electrocardiogram data collection\n* Electrocardiogram data meeting either of the following group definitions:\n\n  * AF with RVR-positive group: atrial fibrillation followed by rapid ventricular response, defined as an average heart rate of 110 beats per minute or greater for at least 30 seconds, with available electrocardiogram data for up to 2 hours before the onset of rapid ventricular response and after the onset in accordance with the protocol\n  * AF with RVR-negative group: atrial fibrillation without rapid ventricular response, with 3 hours of electrocardiogram data available before a selected index time corresponding to a similar time during hospitalization as that used for positive cases\n* If the relevant episode 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 the episode, with a minimum electrocardiogram recording duration of 10 minutes\n* Other data considered suitable for the study by the principal investigator\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* Electrocardiogram data from a participant whose baseline heart rate remained at 110 beats per minute or greater irrespective of atrial fibrillation\n* Data considered unsuitable for this clinical study by the principal investigator",{"count":56,"type":20},348,"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.\n\nA 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.\n\nEligible 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.",[24,59],"Atrial Fibrillation With Rapid Ventricular Response",[59,61,62,29,30,31,32,63],"AF With RVR","Rapid Ventricular Response","SMD-RVECG",{"date":38,"type":39},{"date":41,"type":20},{"date":43,"type":20},{"name":45,"class":46},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100573836","evaluation-of-the-effectiveness-and-safety-of-remote-electrocardiographic-monitoring-in-patients-with-atrial-fibrillation-following-ablation-therapy-100573836","NCT06751459","Evaluation of the Effectiveness and Safety of Remote Electrocardiographic Monitoring in Patients with Atrial Fibrillation Following Ablation Therapy","Patch ECG-based REcurrEnce Monitoring After Catheter Ablation in PaTients with Atrial Fibrillation (PREEMPT-AF) : a Multicenter, Randomized Controlled, Open-label, Prospective Trial","PREEMPT-AF","Inclusion Criteria:\n\n* 1\\. Adults aged 19 years or older who have voluntarily provided written informed consent to participate in this clinical trial.\n\n  2\\. Individuals who have been diagnosed with atrial fibrillation prior to the date of informed consent acquisition.\n\n  3\\. Individuals who are scheduled to undergo catheter ablation for atrial fibrillation within three months from the date of informed consent acquisition.\n\nExclusion Criteria:\n\n* 1\\. Individuals with a history of catheter ablation prior to obtaining informed consent.\n\n  2\\. Individuals with sensitive skin, allergic skin conditions, skin cancer, rashes, or other dermatological disorders.\n\n  3\\. Individuals with implanted cardiac devices, such as pacemakers, implantable defibrillators, or other implantable electronic devices.\n\n  4\\. Individuals deemed by the investigator to be at an increased risk or otherwise unsuitable for participation in the clinical trial.\n\n  5\\. Individuals with cognitive impairments that make it difficult to understand trial information or voluntarily make an informed decision.\n\n  6\\. Pregnant or breastfeeding women.",{"count":77,"type":20},270,"INTERVENTIONAL",[80],"NA","Background:\n\nAtrial fibrillation (AF) is the most common arrhythmia, significantly contributing to complications such as stroke, heart failure, dementia, and increased mortality. Catheter ablation is widely used for treatment, but recurrence rates range from 15-50% within 12 months post-procedure. Conventional intermittent ECG monitoring lacks sufficient sensitivity to detect asymptomatic AF recurrence effectively.\n\nObjective:\n\nTo compare the recurrence rates of atrial tachyarrhythmias between a 1-day monitoring group and a 14-day monitoring group using MEMO Patch 2 after catheter ablation in AF patients. The study also evaluates the effectiveness and safety of early recurrence detection via remote monitoring.\n\nStudy Population:\n\nPatients diagnosed with AF and treated with catheter ablation.\n\nIntervention:\n\nParticipants will undergo three sessions of remote ECG monitoring using MEMO Patch 2 and MEMO Link (first session only), spanning approximately one year after catheter ablation.\n\nHypothesis:\n\nLong-term monitoring with MEMO Patch 2 will be more effective than 1-day monitoring in detecting the recurrence of atrial tachyarrhythmias (including AF, atrial flutter, and atrial tachycardia) following catheter ablation.",[24],[84,85,86,87,88,89],"Atrial fibrillation","circulatory system","EKG","remote monitoring","gateway","MEMO-Patch","2024-12-26",{"date":92,"type":39},"2024-12-31",{"date":94,"type":20},"2025-01-06",{"date":96,"type":20},"2027-03-01",{"name":45,"class":46},7,""]