Congenital Heart Disease in Children
Conditions
Brief summary
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
DEVICECardiac simulator
A computer software cardiac simulator for surgical planning in complex Congenital Heart Disease (CHD) pediatric patients.
Sponsors
National Institutes of Health (NIH)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | At date of hospital discharge or up to 30 days post-operation | Alive or deceased post-operative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Latest follow-up exam up to 3 years post-operation | Alive or deceased long-term |
| Number of cardioplegic arrest | Up to 10 hours | Due to quality of pathways to blood flow, function of inlet and outlet valves, or residual hemodynamic lesions during operation (up to 5 times) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Valvular function | Immediately post-operation, at date of discharge, follow-up to 3 years | Echocardiogram |
| Number of repair revisions needed | At date of hospital discharge or up to 30 days post-operation | Due to quality of pathways to blood flow, function of inlet and outlet valves, residual hemodynamic lesions |
| Type of post-operative inotrope | At discharge date up to approximately 3 weeks | What inotropes were administered post-operation |
| Number of days in hospital post-operation | At discharge date up to 180 days | Length of time from date of operation to discharge from hospital |
| Time on cardiopulmonary bypass | Up to approximately 10 hours intra-operation | Hours and minutes of operative duration |
| Ventricular function | Immediately post-operation, at date of discharge, follow-up to 3 years | Echocardiogram |
Outcome results
None listed