Cardiac Simulator for Surgical Planning

Not Applicable

Not yet recruiting

• Conditions: Congenital Heart Disease in Children
• Interventions: Device: Cardiac simulator

• Registration Number: NCT06373705
• Lead Sponsor: Stanford University

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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-16
• Last Update Submitted: 2024-04-17
• Study First Posted: 2024-04-18
• Last Update Posted: 2024-04-22
• Study Start: 2026-04
• Primary Completion: 2029-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 275

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical planning discussion with aid of cardiac simulator	Cardiac simulator	Surgical planning discussion with aid of cardiac simulator

Primary Outcome Measures

Name	Time	Method
Mortality	At date of hospital discharge or up to 30 days post-operation	Alive or deceased post-operative

Secondary Outcome Measures

Name	Time	Method
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)
Mortality	Latest follow-up exam up to 3 years post-operation	Alive or deceased long-term