Cardiac Simulator for Surgical Planning

NCT06373705 | Not Yet Recruiting

• 2 other identifiers: 745661R01HL173845-01
• Study Type: interventional
• Target: 275
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Congenital Heart Disease in Children

Outcome Measures

Primary Outcomes (1)

• Mortality

  Alive or deceased post-operative

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

Secondary Outcomes (2)

• Mortality

  Latest follow-up exam up to 3 years post-operation

• Number of cardioplegic arrest

  Up to 10 hours

Other Outcomes (10)

• Number of repair revisions needed

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

• Time on cardiopulmonary bypass

  Up to approximately 10 hours intra-operation

• Ventricular function

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

Study Arms (2)

Conventional surgical planning discussion without cardiac simulator

NO INTERVENTION

Conventional surgical planning discussion without cardiac simulator

Surgical planning discussion with aid of cardiac simulator

EXPERIMENTAL

Surgical planning discussion with aid of cardiac simulator

Device: Cardiac simulator

Interventions

Cardiac simulator DEVICE

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

Surgical planning discussion with aid of cardiac simulator

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Adult patients with CHD.

Sponsors & Collaborators

• Stanford University: lead
• National Institutes of Health (NIH): collaborator

Study Officials

• Alison Marsden, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: After consent to participate in the study, patient will be entered into a random allocation sequence for standard of care (SOC) or cardiac simulator groups. Patient and surgeon will both be notified which group they have been assigned to.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DOUGLASS M. AND NOLA LEISHMAN PROFESSOR OF CARDIOVASCULAR DISEASES, PROFESSOR OF PEDIATRICS (CARDIOLOGY) AND OF BIOENGINEERING AND, BY COURTESY, OF MECHANICAL ENGINEERING

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 18, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share