[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544808":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":11,"locations":11,"responsibleParty":27,"collaborators":30,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":11,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":11,"maxAge":42,"enrollmentInfo":43,"targetDuration":11,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":11,"overallStatus":52,"whyStopped":11,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":11},{"fullName":5,"class":6},"Stanford University","OTHER",[8,12],{"label":9,"type":10,"description":9,"interventionNames":11},"Conventional surgical planning discussion without cardiac simulator","NO_INTERVENTION",null,{"label":13,"type":14,"description":13,"interventionNames":15},"Surgical planning discussion with aid of cardiac simulator","EXPERIMENTAL",[16],"Device: Cardiac simulator",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"DEVICE","Cardiac simulator","A computer software cardiac simulator for surgical planning in complex Congenital Heart Disease (CHD) pediatric patients.",[13],[24],{"name":25,"affiliation":5,"role":26},"Alison Marsden, PhD","PRINCIPAL_INVESTIGATOR",{"type":26,"investigatorFullName":28,"investigatorTitle":29,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Alison Lesley Marsden","DOUGLASS M. AND NOLA LEISHMAN PROFESSOR OF CARDIOVASCULAR DISEASES, PROFESSOR OF PEDIATRICS (CARDIOLOGY) AND OF BIOENGINEERING AND, BY COURTESY, OF MECHANICAL ENGINEERING",[31],{"name":32,"class":33},"National Institutes of Health (NIH)","NIH","100544808","cardiac-simulator-for-surgical-planning-100544808",false,"NCT06373705","Cardiac Simulator for Surgical Planning","Utilizing a Multi-Physics Cardiac Simulator for Surgical Planning in Complex Congenital Heart Disease Pediatric Patients","Inclusion Criteria:\n\n* The inclusion criteria are pediatric patients ages 0-17 with a congenital heart disease (CHD) diagnosis of 1) congenitally corrected transposition of the great arteries (cc-TGA) with ventricular septal defect (VSD), 2) double outlet right ventricle (DORV) with remote VSD, or 3) other single ventricle conditions.\n\nExclusion Criteria:\n\n* Adult patients with CHD.","ALL","17 Years",{"count":44,"type":45},275,"ESTIMATED","INTERVENTIONAL",[48],"NA","The goal of this clinical trial is to learn if a computer software program (cardiac simulator) for surgical planning will lead to improvements in patient care by decreasing the incidence of unsuccessful interventions and reinterventions for pediatric patients with congenital heart disease. It is not a commercially available device to treat congenital heart disease in pediatric patients. The main aims are:\n\nTo provide safe pre-operative testing of surgical approaches with a computer model cardiac simulator.\n\nTo aid surgeons in envisioning different surgical approaches for each individual patient.\n\nTo bolster the standard of care surgical planning discussions which will be particularly useful for patients with unique, complex congenital heart disease.\n\nParticipants will:\n\nConsent to being randomized with a 50% chance of receiving standard of care \"on the fly\" surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of the computer software cardiac simulator.\n\nReceive results of their computer simulated findings during their surgical planning discussion if they are in the cardiac simulator group.",[51],"Congenital Heart Disease in Children","NOT_YET_RECRUITING","2024-04-17",{"date":55,"type":56},"2024-04-22","ACTUAL",{"date":58,"type":45},"2026-04",{"date":60,"type":45},"2029-04",{"name":5,"class":6}]