Cardiac Simulator for Surgical Planning

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-30

Study Completion Date

2029-04-30

Brief Summary

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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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Detailed Description

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

Conditions

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Congenital Heart Disease in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

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.

Study Groups

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Conventional surgical planning discussion without cardiac simulator

Group Type NO_INTERVENTION

No interventions assigned to this group

Surgical planning discussion with aid of cardiac simulator

Group Type EXPERIMENTAL

Cardiac simulator

Intervention Type DEVICE

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

Interventions

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