Cardiac Simulator for Surgical Planning
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardiac simulator.
- Who it may be relevant to
- Registry conditions: Congenital Heart Disease in Children. Basic parameters: up to 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Utilizing a Multi-Physics Cardiac Simulator for Surgical Planning in Complex Congenital Heart Disease Pediatric Patients
Overview
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.
Detailed description
The computer software will be developed at the Cardiovascular Biomechanics Computation Lab at Stanford.
Interventions
- Device Cardiac simulator
A computer software cardiac simulator for surgical planning in complex Congenital Heart Disease (CHD) pediatric patients.
Primary outcome measures
- Mortality [Time frame: At date of hospital discharge or up to 30 days post-operation]
Secondary outcome measures (2)
- Mortality [Time frame: Latest follow-up exam up to 3 years post-operation]
- Number of cardioplegic arrest [Time frame: Up to 10 hours]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Adult patients with CHD.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06373705 · 74566 · 1R01HL173845-01