[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571217":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":25,"studyPopulation":17,"armGroups":26,"interventions":33,"overallOfficials":39,"centralContacts":44,"locations":54,"responsibleParty":68,"collaborators":17,"id":70,"slug":17,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":17,"enrollmentInfo":78,"targetDuration":17,"studyType":81,"phases":82,"briefSummary":83,"conditions":84,"keywords":17,"overallStatus":56,"whyStopped":17,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Caption Health, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Sensitivity and Specificity","The primary endpoints are the sensitivity and specificity of the Caption AutoAS algorithm for the absence (none\u002Fmild AS) or presence (moderate\u002Fsevere AS) of AS relative to that indicated in the echocardiographic examination.","At the time of the examination",[14],{"measure":15,"description":16,"timeFrame":12},"Subgroup analysis of outcome 1","Subgroup Analyses: Sensitivity and specificity will be calculated for the following sub-groups. BMI group (\\\u003C 25, ≥ 25-30, ≥ 30), sex, and age (\\\u003C65, ≥65)",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"NA","SINGLE_GROUP","This is a prospective, non-randomized, un-blinded study in patients scheduled for a standard echocardiographic examination.","DIAGNOSTIC",{"masking":24,"maskingDescription":17,"whoMasked":17},"NONE","This is a non-randomized, un-blinded single-arm study in patients scheduled for a standard echocardiographic examination. Participants will be scanned by a sonographer (Study Exam) and 6 standard views will be obtained using both the ultrasound systems: PLAX, PSAX-AV, AP4, AP2, AP3 and AP5 .\n\nThe patient will undergo their scheduled echocardiographic examination either before or after the study examinations.\n\nThe findings from the clinically indicated echocardiographic examination will be used as a gold standard for the presence\u002Fabsence and severity of aortic stenosis.\n\nThe first 45 patients, 15 with mild, 15 with moderate and 15 with severe AS, will be used for testing and possible fine-tuning the AutoAS algorithm for each Study Device, and the remaining up to 155 patients for each Study Device will be used for clinical validation of the algorithm. Because these first 45 patients will only be used for possible fine-tuning the AutoAS algorithm, they will be excluded from endpoint analysis.",[27],{"label":28,"type":29,"description":30,"interventionNames":31},"Single Arm","OTHER","There is no investigational device being used. Devices to be used are Vscan Air and Venue Ultrasound systems",[32],"Device: AutoAS",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":17},"DEVICE","AutoAS","AutoAS is an artificial intelligence algorithm that will be tested retrospectively on the images acquired as part of the study",[28],[40],{"name":41,"affiliation":42,"role":43},"Akhil Narang, MD","Northwestern University","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":17,"email":49},"Yngvil K Thomas, MSc","CONTACT","+1 312-316-5632","yngvil.thomas@gehealthcare.com",{"name":51,"role":47,"phone":52,"phoneExt":17,"email":53},"Angeline Trinidad, BA","+1 310-940-9162","Angeline.Trinidad@gehealthcare.com",[55],{"facility":42,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":17},"RECRUITING","Chicago","Illinois","60208","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-87.65005,41.85003,{"lat":66,"lon":65},{"type":69,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100571217",false,"NCT06717373","Point-of-Care Echocardiography in Patients with Known or Suspected Aortic Stenosis","POC","Inclusion Criteria:\n\n* Patients scheduled for an echocardiographic examination\n* Patients ≥18 years old\n* Patient with known or suspected valve disease based on medical history\n\nExclusion Criteria:\n\n* Patients with artificial aortic valves\n* Unable to lie flat for study\n* Patients experiencing a known or suspected acute cardiac event\n* Patients unwilling or unable to give written informed consent","ALL","18 Years",{"count":79,"type":80},200,"ESTIMATED","INTERVENTIONAL",[19],"This is a prospective clinical trial intended to capture echocardiographic images in patients clinically indicated for an echocardiographic examination using an additional Point of Care Ultrasound device . The images collected will be used to test and possibly validation an AI base Aortic Valve Stenosis algorithm",[85],"Patients with an Indication for an Echocardiographic Examination with Suspicion of Valcular Heart Disease","2025-02-10",{"date":88,"type":89},"2025-02-12","ACTUAL",{"date":91,"type":89},"2025-02-07",{"date":93,"type":80},"2025-04-01",{"name":5,"class":6},1]