Cardiac Simulator for Surgical Planning

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Congenital Heart Disease in Children
• Intervention / Treatment: Device: Cardiac simulator

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 275
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional surgical planning discussion without cardiac simulator
Experimental: Surgical planning discussion with aid of cardiac simulator	Device: Cardiac simulator; A computer software cardiac simulator for surgical planning in complex Congenital Heart Disease (CHD) pediatric patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Alive or deceased post-operative	At date of hospital discharge or up to 30 days post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Alive or deceased long-term	Latest follow-up exam up to 3 years post-operation
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Time on cardiopulmonary bypass	Hours and minutes of operative duration	Up to approximately 10 hours intra-operation
Ventricular function	Echocardiogram	Immediately post-operation, at date of discharge, follow-up to 3 years
Ventricular function	MRI	At 1 year post-operation
Valvular function	Echocardiogram	Immediately post-operation, at date of discharge, follow-up to 3 years
Valvular function	MRI	At 1 year post-operation
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
Type of post-operative inotrope	What inotropes were administered post-operation	At discharge date up to approximately 3 weeks
Ventricular function	Catheterization	At 1 year post-operation
Valvular function	Catheterization	Valvular function

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Alison Marsden, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 74566; 1R01HL173845 - 01 (Other Grant/Funding Number: NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No