[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594750":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":37,"responsibleParty":54,"collaborators":18,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":18,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":18,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"National Defense Medical Center, Taiwan","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AI-ECG","EXPERIMENTAL","Participants whose electrocardiogram is classified as high-risk for moderate or severe valvular heart disease (VHD) by the artificial intelligence-powered electrocardiogram (AI-ECG) system will receive additional transthoracic echocardiography, regardless of whether the treating physician suspects VHD based on symptoms or physical examination.\n\nLow-risk participants continue with routine care without additional intervention.",[13],"Diagnostic Test: AI-ECG driven echocardiography",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual care","NO_INTERVENTION","Participants whose electrocardiogram is classified as high-risk for moderate or severe valvular heart diseases (VHD) by the artificial intelligence-powered electrocardiogram (AI-ECG) system receive standard care according to routine clinical practice. Transthoracic echocardiography is arranged only if the treating physician deems it clinically necessary based on the symptoms, physical examination, , or other non-AI findings.\n\nLow-risk participants continue with routine care without additional intervention.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DIAGNOSTIC_TEST","AI-ECG driven echocardiography","The intervention utilizes a previously validated deep learning model based on 12-lead electrocardiogram (ECG) data to screen for moderate-to-severe valvular heart diseases (VHD). The model processes raw ECG signals and integrates age and sex to enhance prediction. (doi: 10.18632\u002Faging.205835.) Participants identified as high-risk for any moderate-to-severe VHD by the algorithm of artificial intelligence-powered electrocardiogram (AI-ECG) in this intervention arm will receive transthoracic echocardiography to confirm diagnosis and guide further management.",[9],[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Chin Lin","CONTACT","+886-2-8792-3100","18574","xup6fup0629@gmail.com",{"name":33,"role":28,"phone":34,"phoneExt":35,"email":36},"Yu-Lan Liu","+886-2-87923311","16118","cylgist80131@gmail.com",[38],{"facility":39,"status":40,"city":41,"state":18,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Tri-Service General Hospital","RECRUITING","Taipei","Taiwan","TW",{"type":45,"coordinates":46},"Point",[47,48],121.52639,25.05306,{"lat":48,"lon":47},[51],{"name":52,"role":28,"phone":34,"phoneExt":18,"email":53},"Yuan-Hao Chen","chenyh178@gmail.com",{"type":55,"investigatorFullName":33,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Doctor of Medicine","100594750","the-valve-ai-trial-100594750",false,"NCT07023510","The VALVE-AI Trial","VALidation of Screening Valvular Heart Disease Using Electrocardiogram Powered by Artificial Intelligence: A Randomized Controlled Trial","Inclusion Criteria:\n\n* At least one 12-lead ECG within 1 year\n* Age 60-85 years of age\n\nExclusion Criteria:\n\n* Documented echocardiography within 3 years before indexed ECG\n* Any known valvular heart disease\n* History of any valvular surgery\n* Post-heart transplant","ALL","60 Years","85 Years",{"count":68,"type":69},8648,"ESTIMATED","INTERVENTIONAL",[72],"NA","The goal of this clinical trial is to learn if an artificial intelligence-powered electrocardiogram (AI-ECG) can help detect moderate or severe valvular heart diseases (VHD) in adults. The main question it aims to answer is:\n\n．Can AI-ECG screening identify patients with significant heart valve diseases who may benefit from early echocardiography? Researchers will compare the rate of moderate or severe VHD detection between the experimental group and the control group to see if AI-ECG improve the detection rate of significant VHD.\n\nParticipants will:\n\n* Be classified as high- or low-risk for VHD using an AI-ECG system\n* In the experimental group, high-risk participants will receive echocardiography based on AI-ECG results\n* In the control group, usual clinical care will be provided without routine echocardiography for AI-ECG high-risk results.",[75],"Valvular Heart Disease Patients","2025-06-23",{"date":78,"type":79},"2025-06-26","ACTUAL",{"date":81,"type":69},"2025-07-01",{"date":83,"type":69},"2026-07-01",{"name":5,"class":6},1]