[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573836":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":42,"responsibleParty":131,"collaborators":27,"id":133,"slug":134,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":135,"sex":141,"minAge":142,"maxAge":27,"enrollmentInfo":143,"targetDuration":27,"studyType":146,"phases":147,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":159,"whyStopped":27,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"HUINNO Co., Ltd","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group","EXPERIMENTAL","Participants in this clinical trial will undergo a total of three remote electrocardiographic (ECG) monitoring sessions during the study period following catheter ablation:\n\n1. st Monitoring: At the time of discharge after catheter ablation, remote ECG monitoring will be performed for 14 days using both the MEMO Patch 2 and MEMO Link.\n2. nd Monitoring: Approximately three months after catheter ablation, remote ECG monitoring will be performed for 14 days using only the MEMO Patch 2.\n3. rd Monitoring: Approximately one year after catheter ablation, remote ECG monitoring will again be performed for 14 days using only the MEMO Patch 2.",[13,14],"Device: MEMO Patch 2 - 1-day Monitoring","Device: MEMO Link",{"label":16,"type":17,"description":18,"interventionNames":19},"Active Comparator Group","ACTIVE_COMPARATOR","Participants in this clinical trial will undergo a total of three remote electrocardiographic (ECG) monitoring sessions during the study period following catheter ablation:\n\n1. st Monitoring: At the time of discharge after catheter ablation, remote ECG monitoring will be conducted for 14 days using both the MEMO Patch 2 and MEMO Link.\n2. nd Monitoring: Approximately three months after catheter ablation, remote ECG monitoring will be conducted for 1 day using only the MEMO Patch 2.\n3. rd Monitoring: Approximately one year after catheter ablation, remote ECG monitoring will be conducted for 14 days using only the MEMO Patch 2.",[20,14],"Device: MEMO Patch 2 - 14-day Monitoring",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","MEMO Patch 2 - 14-day Monitoring","A wearable ECG monitoring device used for continuous 14-day monitoring to detect atrial arrhythmias during the second monitoring phase (at 3 months post-ablation). MEMO Patch 2 collects ECG data for remote analysis to assess early recurrence of atrial arrhythmias.",[16],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"MEMO Patch 2 - 1-day Monitoring","A wearable ECG monitoring device used for 1-day monitoring during the second monitoring phase (at 3 months post-ablation). MEMO Patch 2 collects ECG data for remote analysis to detect early recurrence of atrial arrhythmias.",[9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"MEMO Link","A supplementary ECG monitoring device used alongside MEMO Patch 2 during the 1st monitoring session.",[16,9],[37],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Jong-il Choi","CONTACT","+821021225476","stabler92@gmail.com",[43,59,70,84,98,109,120],{"facility":44,"status":27,"city":45,"state":27,"zip":46,"country":47,"countryCode":27,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Dong-A University Hospital","Busan","49201","South Korea",{"type":49,"coordinates":50},"Point",[51,52],129.03004,35.10168,{"lat":52,"lon":51},[55],{"name":56,"role":39,"phone":57,"phoneExt":27,"email":58},"Jongseong Park","+82-51-240-5040","thinkmed@naver.com",{"facility":60,"status":27,"city":45,"state":27,"zip":61,"country":47,"countryCode":27,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Busan National University Hospital","49241",{"type":49,"coordinates":63},[51,52],{"lat":52,"lon":51},[66],{"name":67,"role":39,"phone":68,"phoneExt":27,"email":69},"Jinhee An","+82-51-240-7794","reinee81@naver.com",{"facility":71,"status":27,"city":72,"state":27,"zip":73,"country":47,"countryCode":27,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Seoul National University Bundang Hospital","Seongnam","13620",{"type":49,"coordinates":75},[76,77],127.7548,36.4052,{"lat":77,"lon":76},[80],{"name":81,"role":39,"phone":82,"phoneExt":27,"email":83},"Ilyoung Oh","+82-10-8620-0510","spy510@snu.ac.kr",{"facility":85,"status":27,"city":86,"state":27,"zip":87,"country":47,"countryCode":27,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Korea University Anam Hospital","Seoul","02855",{"type":49,"coordinates":89},[90,91],126.9784,37.566,{"lat":91,"lon":90},[94],{"name":95,"role":39,"phone":96,"phoneExt":27,"email":97},"Jongil Choi","+82-10-2122-5476","jongilchoi@korea.ac.kr",{"facility":99,"status":27,"city":86,"state":27,"zip":100,"country":47,"countryCode":27,"cosmosGeoPoint":101,"geoPoint":103,"contacts":104},"Asan Medical Center","05505",{"type":49,"coordinates":102},[90,91],{"lat":91,"lon":90},[105],{"name":106,"role":39,"phone":107,"phoneExt":27,"email":108},"Gibyung Nam","+82-10-3127-5681","gbnam@amc.seoul.kr",{"facility":110,"status":27,"city":86,"state":27,"zip":111,"country":47,"countryCode":27,"cosmosGeoPoint":112,"geoPoint":114,"contacts":115},"Ewha Womans University Seoul Hospital","07804",{"type":49,"coordinates":113},[90,91],{"lat":91,"lon":90},[116],{"name":117,"role":39,"phone":118,"phoneExt":27,"email":119},"Donghyuk Kim","+82-10-2724-7740","tomas9912@naver.com",{"facility":121,"status":27,"city":86,"state":27,"zip":122,"country":47,"countryCode":27,"cosmosGeoPoint":123,"geoPoint":125,"contacts":126},"Korea University Guro Hospital","08308",{"type":49,"coordinates":124},[90,91],{"lat":91,"lon":90},[127],{"name":128,"role":39,"phone":129,"phoneExt":27,"email":130},"Seungyoung Ro","+82-10-3612-6876","rsy008@gmail.com",{"type":132,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100573836","evaluation-of-the-effectiveness-and-safety-of-remote-electrocardiographic-monitoring-in-patients-with-atrial-fibrillation-following-ablation-therapy-100573836",false,"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.","ALL","19 Years",{"count":144,"type":145},270,"ESTIMATED","INTERVENTIONAL",[148],"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.",[151],"Atrial Fibrillation (AF)",[153,154,155,156,157,158],"Atrial fibrillation","circulatory system","EKG","remote monitoring","gateway","MEMO-Patch","NOT_YET_RECRUITING","2024-12-26",{"date":162,"type":163},"2024-12-31","ACTUAL",{"date":165,"type":145},"2025-01-06",{"date":167,"type":145},"2027-03-01",{"name":5,"class":6},7]