Cardiac Simulator for Surgical Planning
ConditionCongenital Heart Disease in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 17
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Adult patients with CHD.
Trial design
Design model
Parallel
Treatments tested in this trial
Cardiac simulator
DeviceA computer software cardiac simulator for surgical planning in complex Congenital Heart Disease (CHD) pediatric patients.
Treatment groups
275 Participants
are divided into 2 treatment groupsGroup A: Conventional surgical planning discussion without cardiac simulatorNo intervention 0 interventions
Group B: Surgical planning discussion with aid of cardiac simulatorExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mortality
Alive or deceased post-operative
Time frame
At date of hospital discharge or up to 30 days post-operationSecondary outcomes
1
Mortality
Alive or deceased long-term
Time frame
Latest follow-up exam up to 3 years post-operation2
Number of cardioplegic arrest
Due to quality of pathways to blood flow, function of inlet and outlet valves, or residual hemodynamic lesions during operation (up to 5 times)
Time frame
Up to 10 hoursOther outcomes
1
Number of repair revisions needed
Due to quality of pathways to blood flow, function of inlet and outlet valves, residual hemodynamic lesions
Time frame
At date of hospital discharge or up to 30 days post-operation2
Time on cardiopulmonary bypass
Hours and minutes of operative duration
Time frame
Up to approximately 10 hours intra-operation3
Ventricular function
Echocardiogram
Time frame
Immediately post-operation, at date of discharge, follow-up to 3 years4
Ventricular function
MRI
Time frame
At 1 year post-operationLocations
Sponsors and contacts
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Stanford University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: