[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630366":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":332,"collaborators":335,"id":339,"slug":340,"hasResults":341,"nctId":342,"briefTitle":343,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":341,"sex":346,"minAge":347,"maxAge":26,"enrollmentInfo":348,"targetDuration":26,"studyType":351,"phases":352,"briefSummary":354,"conditions":355,"keywords":357,"overallStatus":362,"whyStopped":26,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":372},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transthoracic Echocardiography-Guided Assessment Group (TTE group)","ACTIVE_COMPARATOR","Participants in this group will receive a standard-of-care evaluation. Cardiac function and structure will be evaluated using Transthoracic Echocardiography (TTE) regardless of ECG findings. Management (anticoagulation, rate\u002Frhythm control) is initiated or adjusted based on TTE parameters. TTE is performed at least once annually during follow-up.",[13],"Diagnostic Test: Transthoracic Echocardiography-Guided Assessment",{"label":15,"type":16,"description":17,"interventionNames":18},"AI-ECG-Guided Assessment Group (AI-ECG group)","EXPERIMENTAL","Participants in this group will undergo a conditional diagnostic strategy. Cardiac function and structure are initially screened using an AI-enabled ECG.\n\n1. Predicted Normal: TTE is withheld. Management is based on clinical evaluation and AI-ECG results.\n2. Predicted Abnormal: Verification TTE is performed. Management is guided by TTE findings.\n\nSafety Note: Protocol-defined rescue TTE is permitted at the investigator's discretion for worsening symptoms or prior to procedures (cardioversion, ablation), regardless of AI-ECG results.",[19],"Diagnostic Test: Artificial intelligence-enabled electrocardiography",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","Artificial intelligence-enabled electrocardiography","An artificial intelligence algorithm applied to standard 12-lead electrocardiography designed to predict cardiac structural or functional abnormalities. This tool guides the decision to perform or withhold downstream echocardiography.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Transthoracic Echocardiography-Guided Assessment","Standard Transthoracic Echocardiography used to assess cardiac structure and function, serving as the reference standard for guiding clinical management in this study arm.",[9],[32],{"name":33,"affiliation":5,"role":34},"Eue-Keun Choi, M.D. Ph.D.","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Eue-Keun Choi, MD, PhD","CONTACT","82-2-2072-0688","choiek417@gmail.com",[42,56,68,80,92,104,116,125,134,146,158,170,179,191,203,212,221,230,239,248,257,266,275,284,293,299,308,320],{"facility":43,"status":26,"city":44,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Korea University Ansan Hospital","Ansan","South Korea",{"type":47,"coordinates":48},"Point",[49,50],126.50748,36.38237,{"lat":50,"lon":49},[53],{"name":54,"role":38,"phone":26,"phoneExt":26,"email":55},"Seung-Yong Shin","theshin04@korea.ac.kr",{"facility":57,"status":26,"city":58,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Hallym University Sacred Heart Hospital","Anyang",{"type":47,"coordinates":60},[61,62],127.49001,35.62128,{"lat":62,"lon":61},[65],{"name":66,"role":38,"phone":26,"phoneExt":26,"email":67},"Sang-Jin Han","medhan69@hallym.or.kr",{"facility":69,"status":26,"city":70,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Dong-A University Hospital","Busan",{"type":47,"coordinates":72},[73,74],129.03004,35.10168,{"lat":74,"lon":73},[77],{"name":78,"role":38,"phone":26,"phoneExt":26,"email":79},"Jong-Sung 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Center","Daegu",{"type":47,"coordinates":108},[109,110],128.59111,35.87028,{"lat":110,"lon":109},[113],{"name":114,"role":38,"phone":26,"phoneExt":26,"email":115},"Young-Soo Lee","mdleeys@cu.ac.kr",{"facility":117,"status":26,"city":106,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":118,"geoPoint":120,"contacts":121},"Keimyung University Dongsan Hospital",{"type":47,"coordinates":119},[109,110],{"lat":110,"lon":109},[122],{"name":123,"role":38,"phone":26,"phoneExt":26,"email":124},"Hyung-Sup Park","drparkgyver@gmail.com",{"facility":126,"status":26,"city":106,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":127,"geoPoint":129,"contacts":130},"Kyungpook National University Chilgok Hospital",{"type":47,"coordinates":128},[109,110],{"lat":110,"lon":109},[131],{"name":132,"role":38,"phone":26,"phoneExt":26,"email":133},"Park Yoon-Jung","blue8685@gmail.com",{"facility":135,"status":26,"city":136,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Chonnam National University Hospital","Gwangju",{"type":47,"coordinates":138},[139,140],126.91556,35.15472,{"lat":140,"lon":139},[143],{"name":144,"role":38,"phone":26,"phoneExt":26,"email":145},"Yoon Nam-Sik","nsaids77@daum.net",{"facility":147,"status":26,"city":148,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Gachon University Gil Medical Center","Incheon",{"type":47,"coordinates":150},[151,152],126.70515,37.45646,{"lat":152,"lon":151},[155],{"name":156,"role":38,"phone":26,"phoneExt":26,"email":157},"Ye-Min Park","ypruimin@gilhospital.com",{"facility":159,"status":26,"city":160,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Jeonbuk National University Hospital","Jeonju",{"type":47,"coordinates":162},[163,164],127.14889,35.82194,{"lat":164,"lon":163},[167],{"name":168,"role":38,"phone":26,"phoneExt":26,"email":169},"Jung Rae-Young","youngjoin@naver.com",{"facility":171,"status":26,"city":160,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":172,"geoPoint":174,"contacts":175},"Presbyterian Medical Center (Jesus Hospital)",{"type":47,"coordinates":173},[163,164],{"lat":164,"lon":163},[176],{"name":177,"role":38,"phone":26,"phoneExt":26,"email":178},"Sun-Hwa Kim","epcardiokim@gmail.com",{"facility":180,"status":26,"city":181,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"CHA Bundang Medical Center","Seongnam",{"type":47,"coordinates":183},[184,185],127.7548,36.4052,{"lat":185,"lon":184},[188],{"name":189,"role":38,"phone":26,"phoneExt":26,"email":190},"Jung-Hoon 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Hospital",{"type":47,"coordinates":215},[196,197],{"lat":197,"lon":196},[218],{"name":219,"role":38,"phone":26,"phoneExt":26,"email":220},"Sung-Jin Park","ferryst@naver.com",{"facility":222,"status":26,"city":193,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":223,"geoPoint":225,"contacts":226},"Ewha Womans University Seoul Hospital",{"type":47,"coordinates":224},[196,197],{"lat":197,"lon":196},[227],{"name":228,"role":38,"phone":26,"phoneExt":26,"email":229},"Ye-Ji Kim","lexie6169@gmail.com",{"facility":231,"status":26,"city":193,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":232,"geoPoint":234,"contacts":235},"Gangnam Severance Hospital",{"type":47,"coordinates":233},[196,197],{"lat":197,"lon":196},[236],{"name":237,"role":38,"phone":26,"phoneExt":26,"email":238},"Kim In-Soo","insooya1203@yuhs.ac",{"facility":240,"status":26,"city":193,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":241,"geoPoint":243,"contacts":244},"Hanyang University Hospital",{"type":47,"coordinates":242},[196,197],{"lat":197,"lon":196},[245],{"name":246,"role":38,"phone":26,"phoneExt":26,"email":247},"Jin-Kyu Park","cardiohy@hanyang.ac.kr",{"facility":249,"status":26,"city":193,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":250,"geoPoint":252,"contacts":253},"Kangbuk Samsung Hospital",{"type":47,"coordinates":251},[196,197],{"lat":197,"lon":196},[254],{"name":255,"role":38,"phone":26,"phoneExt":26,"email":256},"Min Kim","minpupets01.kim@samsung.com",{"facility":258,"status":26,"city":193,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":259,"geoPoint":261,"contacts":262},"Korea University Guro Hospital",{"type":47,"coordinates":260},[196,197],{"lat":197,"lon":196},[263],{"name":264,"role":38,"phone":26,"phoneExt":26,"email":265},"Kyung-Yeon Lee","managingheart@gmail.com",{"facility":267,"status":26,"city":193,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":268,"geoPoint":270,"contacts":271},"Kyung Hee University Hospital at Gangdong",{"type":47,"coordinates":269},[196,197],{"lat":197,"lon":196},[272],{"name":273,"role":38,"phone":26,"phoneExt":26,"email":274},"Eun-Sun Jin","esjin@khu.ac.kr",{"facility":276,"status":26,"city":193,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":277,"geoPoint":279,"contacts":280},"Kyung Hee University Medical Center",{"type":47,"coordinates":278},[196,197],{"lat":197,"lon":196},[281],{"name":282,"role":38,"phone":26,"phoneExt":26,"email":283},"Jin-Bae Kim","jinbbai@khu.ac.kr",{"facility":285,"status":26,"city":193,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":286,"geoPoint":288,"contacts":289},"Samsung Medical Center",{"type":47,"coordinates":287},[196,197],{"lat":197,"lon":196},[290],{"name":291,"role":38,"phone":26,"phoneExt":26,"email":292},"Young-Keun Ohn","yk.on@samsung.com",{"facility":5,"status":26,"city":193,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":294,"geoPoint":296,"contacts":297},{"type":47,"coordinates":295},[196,197],{"lat":197,"lon":196},[298],{"name":37,"role":38,"phone":26,"phoneExt":26,"email":40},{"facility":300,"status":26,"city":193,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":301,"geoPoint":303,"contacts":304},"Severance Hospital",{"type":47,"coordinates":302},[196,197],{"lat":197,"lon":196},[305],{"name":306,"role":38,"phone":26,"phoneExt":26,"email":307},"Dae-Hoon Kim","kimdhoon@yuhs.ac",{"facility":309,"status":26,"city":310,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":311,"geoPoint":315,"contacts":316},"Ajou University Hospital","Suwon",{"type":47,"coordinates":312},[313,314],127.00889,37.29111,{"lat":314,"lon":313},[317],{"name":318,"role":38,"phone":26,"phoneExt":26,"email":319},"Do-Young Kim","sneeze_kr@naver.com",{"facility":321,"status":26,"city":322,"state":26,"zip":26,"country":45,"countryCode":26,"cosmosGeoPoint":323,"geoPoint":327,"contacts":328},"Pusan National University Yangsan Hospital","Yangsan",{"type":47,"coordinates":324},[325,326],129.03358,35.34199,{"lat":326,"lon":325},[329],{"name":330,"role":38,"phone":26,"phoneExt":26,"email":331},"Hwang Ki-Won","korea.hwang@gmail.com",{"type":34,"investigatorFullName":333,"investigatorTitle":334,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Eue-Keun Choi","Professor",[336],{"name":337,"class":338},"Medical AI","INDUSTRY","100630366","functional-and-structural-assesment-of-the-heart-by-artificial-intelligence-enabled-electrocardiogram-for-the-management-of-atrial-fibrillation-100630366",false,"NCT07486739","Functional And STructural Assesment of the Heart by Artificial Intelligence-enabled Electrocardiogram for the Management of Atrial Fibrillation","FAST-AF","Inclusion Criteria:\n\n1. AF documented by electrocardiography within the past 12 months\n\n   * AF documented on a 12-lead electrocardiogram or recorded for ≥30 seconds on a single-lead or multi-lead electrocardiogram.\n2. Patients for whom an initial or repeat transthoracic echocardiographic evaluation is clinically indicated.\n3. A CHA₂DS₂-VA score of ≥2.\n4. Aged ≥19 years at the time of enrollment and able to provide written informed consent voluntarily.\n\nExclusion Criteria:\n\n1. Transthoracic echocardiography performed within the past 6 months.\n2. Ventricular rate ≥110 beats per minute during atrial fibrillation.\n3. Atrial fibrillation due to a reversible cause.\n4. New York Heart Association (NYHA) functional class IV or European Heart Rhythm Association (EHRA) class IV symptoms.\n5. Known history of structural heart disease or clinical findings suggestive of structural heart disease based on medical history and physical examination. (e.g., presence of a cardiac murmur of Levine scale grade 3 or higher on auscultation, or murmurs suggestive of moderate to severe mitral stenosis, such as an opening snap or diastolic rumbling murmur).\n6. Baseline electrocardiographic conduction abnormalities or significant electrocardiographic findings suggestive of clinically meaningful structural heart disease (e.g., Mobitz type II second-degree atrioventricular block, third-degree atrioventricular block, or QTc ≥480 ms).\n7. History of prior cardiac surgery.\n8. History of acute coronary syndrome or coronary revascularization within the past 90 days.\n9. History of intracardiac thrombosis or systemic thromboembolism within the past 90 days.\n10. History of transient ischemic attack, ischemic stroke, or intracranial hemorrhage within the past 90 days.\n11. History of ventricular tachycardia or ventricular fibrillation.\n12. Severe liver disease associated with coagulopathy (e.g., AST or ALT \\>3× the upper limit of normal, or total bilirubin \\>2× the upper limit of normal).\n13. Severe chronic kidney disease (stage V), requiring or imminently requiring dialysis.\n14. Contraindication to anticoagulation therapy.\n15. Pregnancy, breastfeeding, or planning pregnancy during the study period.\n16. Life expectancy of less than 1 year.\n17. Current participation in another randomized clinical trial.","ALL","19 Years",{"count":349,"type":350},1724,"ESTIMATED","INTERVENTIONAL",[353],"NA","The objective of this study is to evaluate whether an AI-ECG based screening strategy for detecting cardiac functional and structural abnormalities preserves clinical effectiveness and safety, compared with a conventional strategy of routine echocardiography in patients with AF, thereby demonstrating the non-inferiority of AI-ECG guided care.",[356],"Atrial Fibrillation (AF)",[358,359,360,361],"atrial fibrillation","artificial intelligence","structural heart disease","electrocardiogram","NOT_YET_RECRUITING","2026-07-22",{"date":365,"type":366},"2026-07-23","ACTUAL",{"date":368,"type":350},"2026-07-29",{"date":370,"type":350},"2030-12-31",{"name":5,"class":6},28]