protocolSection identificationModule nctId: NCT06373705, orgStudyIdInfo id: 74566, secondaryIdInfos id: 1R01HL173845 - 01, type: OTHER_GRANT, domain: NIH, briefTitle: Cardiac Simulator for Surgical Planning, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2026-04, primaryCompletionDateStruct date: 2029-04, completionDateStruct date: 2029-04, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, collaborators name: National Institutes of Health (NIH), descriptionModule briefSummary: 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:To provide safe pre-operative testing of surgical approaches with a computer model cardiac simulator.To aid surgeons in envisioning different surgical approaches for each individual patient.To bolster the standard of care surgical planning discussions which will be particularly useful for patients with unique, complex congenital heart disease.Participants will:Consent 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.Receive results of their computer simulated findings during their surgical planning discussion if they are in the cardiac simulator group., conditionsModule conditions: Congenital Heart Disease in Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 1:1 randomization to either receive standard of care "on the fly" surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of computer simulation., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: After consent to participate in the study, patient will be entered into a random allocation sequence for standard of care (SOC) or cardiac simulator groups.Patient and surgeon will both be notified which group they have been assigned to., enrollmentInfo count: 275, type: ESTIMATED, armsInterventionsModule interventions name: Cardiac simulator, outcomesModule primaryOutcomes measure: Mortality, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Number of cardioplegic arrest, otherOutcomes measure: Number of repair revisions needed, otherOutcomes measure: Time on cardiopulmonary bypass, otherOutcomes measure: Ventricular function, otherOutcomes measure: Ventricular function, otherOutcomes measure: Ventricular function, otherOutcomes measure: Valvular function, otherOutcomes measure: Valvular function, otherOutcomes measure: Valvular function, otherOutcomes measure: Number of days in hospital post-operation, otherOutcomes measure: Type of post-operative inotrope, eligibilityModule sex: ALL, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False