Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-01 @ 1:18 AM
Study NCT ID:
NCT06373705
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Simulator for Surgical Planning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', '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.\n\nPatient and surgeon will both be notified which group they have been assigned to.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 275}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2024-04-16', 'studyFirstSubmitQcDate': '2024-04-16', 'lastUpdatePostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of repair revisions needed', 'timeFrame': 'At date of hospital discharge or up to 30 days post-operation', 'description': 'Due to quality of pathways to blood flow, function of inlet and outlet valves, residual hemodynamic lesions'}, {'measure': 'Time on cardiopulmonary bypass', 'timeFrame': 'Up to approximately 10 hours intra-operation', 'description': 'Hours and minutes of operative duration'}, {'measure': 'Ventricular function', 'timeFrame': 'Immediately post-operation, at date of discharge, follow-up to 3 years', 'description': 'Echocardiogram'}, {'measure': 'Ventricular function', 'timeFrame': 'At 1 year post-operation', 'description': 'MRI'}, {'measure': 'Ventricular function', 'timeFrame': 'At 1 year post-operation', 'description': 'Catheterization'}, {'measure': 'Valvular function', 'timeFrame': 'Immediately post-operation, at date of discharge, follow-up to 3 years', 'description': 'Echocardiogram'}, {'measure': 'Valvular function', 'timeFrame': 'At 1 year post-operation', 'description': 'MRI'}, {'measure': 'Valvular function', 'timeFrame': 'Valvular function', 'description': 'Catheterization'}, {'measure': 'Number of days in hospital post-operation', 'timeFrame': 'At discharge date up to 180 days', 'description': 'Length of time from date of operation to discharge from hospital'}, {'measure': 'Type of post-operative inotrope', 'timeFrame': 'At discharge date up to approximately 3 weeks', 'description': 'What inotropes were administered post-operation'}], 'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'At date of hospital discharge or up to 30 days post-operation', 'description': 'Alive or deceased post-operative'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Latest follow-up exam up to 3 years post-operation', 'description': 'Alive or deceased long-term'}, {'measure': 'Number of cardioplegic arrest', 'timeFrame': 'Up to 10 hours', 'description': 'Due to quality of pathways to blood flow, function of inlet and outlet valves, or residual hemodynamic lesions during operation (up to 5 times)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congenital Heart Disease in Children']}, '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:\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.', 'detailedDescription': 'The computer software will be developed at the Cardiovascular Biomechanics Computation Lab at Stanford.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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.'}, 'identificationModule': {'nctId': 'NCT06373705', 'briefTitle': 'Cardiac Simulator for Surgical Planning', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Utilizing a Multi-Physics Cardiac Simulator for Surgical Planning in Complex Congenital Heart Disease Pediatric Patients', 'orgStudyIdInfo': {'id': '74566'}, 'secondaryIdInfos': [{'id': '1R01HL173845-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL173845-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Conventional surgical planning discussion without cardiac simulator', 'description': 'Conventional surgical planning discussion without cardiac simulator'}, {'type': 'EXPERIMENTAL', 'label': 'Surgical planning discussion with aid of cardiac simulator', 'description': 'Surgical planning discussion with aid of cardiac simulator', 'interventionNames': ['Device: Cardiac simulator']}], 'interventions': [{'name': 'Cardiac simulator', 'type': 'DEVICE', 'description': 'A computer software cardiac simulator for surgical planning in complex Congenital Heart Disease (CHD) pediatric patients.', 'armGroupLabels': ['Surgical planning discussion with aid of cardiac simulator']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Alison Marsden, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DOUGLASS M. AND NOLA LEISHMAN PROFESSOR OF CARDIOVASCULAR DISEASES, PROFESSOR OF PEDIATRICS (CARDIOLOGY) AND OF BIOENGINEERING AND, BY COURTESY, OF MECHANICAL ENGINEERING', 'investigatorFullName': 'Alison Lesley Marsden', 'investigatorAffiliation': 'Stanford University'}}}}