NCT06373705

Cardiac Simulator for Surgical Planning

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 275 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Heart Disease in Children

Interventions

Type	Name	Description
DEVICE	Cardiac simulator	A computer software cardiac simulator for surgical planning in complex Congenital Heart Disease (CHD) pediatric patients.

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-04-01
• Completion: 2029-04-01
• First posted: 2024-04-18
• Last updated: 2024-04-22