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NCT Number: NCT06373705

Cardiac Simulator for Surgical Planning

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.

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Key information

Conditions

Congenital Heart Disease in Children

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiac simulator

Device

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

Primary outcomes

  1. Mortality

    Time frame: At date of hospital discharge or up to 30 days post-operation

    Alive or deceased post-operative

Secondary outcomes

  1. Mortality

    Time frame: Latest follow-up exam up to 3 years post-operation

    Alive or deceased long-term

  2. Number of cardioplegic arrest

    Time frame: 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 outcomes

  1. Number of repair revisions needed

    Time frame: 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

  2. Time on cardiopulmonary bypass

    Time frame: Up to approximately 10 hours intra-operation

    Hours and minutes of operative duration

  3. Ventricular function

    Time frame: Immediately post-operation, at date of discharge, follow-up to 3 years

    Echocardiogram

  4. Ventricular function

    Time frame: At 1 year post-operation

    MRI

  5. Ventricular function

    Time frame: At 1 year post-operation

    Catheterization

  6. Valvular function

    Time frame: Immediately post-operation, at date of discharge, follow-up to 3 years

    Echocardiogram

  7. Valvular function

    Time frame: At 1 year post-operation

    MRI

  8. Valvular function

    Time frame: Valvular function

    Catheterization

  9. Number of days in hospital post-operation

    Time frame: At discharge date up to 180 days

    Length of time from date of operation to discharge from hospital

  10. Type of post-operative inotrope

    Time frame: At discharge date up to approximately 3 weeks

    What inotropes were administered post-operation

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 18, 2024
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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