Cardiac Simulator for Surgical Planning

Congenital Heart Disease in Children Clinical Trial

Official title:

Utilizing a Multi-Physics Cardiac Simulator for Surgical Planning in Complex Congenital Heart Disease Pediatric Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06373705
• Other study ID #: 74566
• Secondary ID: 1R01HL173845 - 0
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2026
• Est. completion date: April 2029

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The computer software will be developed at the Cardiovascular Biomechanics Computation Lab at Stanford.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 275
• Est. completion date: April 2029
• Est. primary completion date: April 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease in Children
• Heart Defects, Congenital
• Heart Diseases

Intervention

Device:
• Cardiac simulator
A computer software cardiac simulator for surgical planning in complex Congenital Heart Disease (CHD) pediatric patients.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of repair revisions needed	Due to quality of pathways to blood flow, function of inlet and outlet valves, residual hemodynamic lesions	At date of hospital discharge or up to 30 days post-operation
Other	Time on cardiopulmonary bypass	Hours and minutes of operative duration	Up to approximately 10 hours intra-operation
Other	Ventricular function	Echocardiogram	Immediately post-operation, at date of discharge, follow-up to 3 years
Other	Ventricular function	MRI	At 1 year post-operation
Other	Ventricular function	Catheterization	At 1 year post-operation
Other	Valvular function	Echocardiogram	Immediately post-operation, at date of discharge, follow-up to 3 years
Other	Valvular function	MRI	At 1 year post-operation
Other	Valvular function	Catheterization	Valvular function
Other	Number of days in hospital post-operation	Length of time from date of operation to discharge from hospital	At discharge date up to 180 days
Other	Type of post-operative inotrope	What inotropes were administered post-operation	At discharge date up to approximately 3 weeks
Primary	Mortality	Alive or deceased post-operative	At date of hospital discharge or up to 30 days post-operation
Secondary	Mortality	Alive or deceased long-term	Latest follow-up exam up to 3 years post-operation
Secondary	Number of cardioplegic arrest	Due to quality of pathways to blood flow, function of inlet and outlet valves, or residual hemodynamic lesions during operation (up to 5 times)	Up to 10 hours