Clinical trial NCT06373705: Cardiac Simulator for Surgical Planning
Official title: Utilizing a Multi-Physics Cardiac Simulator for Surgical Planning in Complex Congenital Heart Disease Pediatric Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Congenital Heart Disease in Children
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2024-04-18
Enrollment: 275
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Mortality
timeFrame: At date of hospital discharge or up to 30 days post-operation
Secondary outcomes:
measure: Mortality
timeFrame: Latest follow-up exam up to 3 years post-operation
measure: Number of cardioplegic arrest
timeFrame: Up to 10 hours
Other outcomes:
measure: Number of repair revisions needed
timeFrame: At date of hospital discharge or up to 30 days post-operation
measure: Time on cardiopulmonary bypass
timeFrame: Up to approximately 10 hours intra-operation
measure: Ventricular function
timeFrame: Immediately post-operation, at date of discharge, follow-up to 3 years
measure: Ventricular function
timeFrame: At 1 year post-operation
measure: Ventricular function
timeFrame: At 1 year post-operation
measure: Valvular function
timeFrame: Immediately post-operation, at date of discharge, follow-up to 3 years
measure: Valvular function
timeFrame: At 1 year post-operation
measure: Valvular function
timeFrame: Valvular function
measure: Number of days in hospital post-operation
timeFrame: At discharge date up to 180 days
measure: Type of post-operative inotrope
timeFrame: At discharge date up to approximately 3 weeks
Locations:
Study officials:
affiliation: Stanford University
name: Alison Marsden, PhD
role: PRINCIPAL_INVESTIGATOR
References: