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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL173845-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
The computer software will be developed at the Cardiovascular Biomechanics Computation Lab at Stanford.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac simulator | Device | A computer software cardiac simulator for surgical planning in complex Congenital Heart Disease (CHD) pediatric patients. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Alive or deceased post-operative | At date of hospital discharge or up to 30 days post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Alive or deceased long-term | Latest follow-up exam up to 3 years post-operation |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of repair revisions needed | Due to quality of pathways to blood flow, function of inlet and outlet valves, residual hemodynamic lesions | At date of hospital discharge or up to 30 days post-operation |
| Time on cardiopulmonary bypass |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Marsden, PhD | Stanford University | Principal Investigator |
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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.
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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.
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| Up to 10 hours |
Hours and minutes of operative duration
| Up to approximately 10 hours intra-operation |
| Ventricular function | Echocardiogram | Immediately post-operation, at date of discharge, follow-up to 3 years |
| Ventricular function | MRI | At 1 year post-operation |
| Ventricular function | Catheterization | At 1 year post-operation |
| Valvular function | Echocardiogram | Immediately post-operation, at date of discharge, follow-up to 3 years |
| Valvular function | MRI | At 1 year post-operation |
| Valvular function | Catheterization | Valvular function |
| Number of days in hospital post-operation | Length of time from date of operation to discharge from hospital | At discharge date up to 180 days |
| Type of post-operative inotrope | What inotropes were administered post-operation | At discharge date up to approximately 3 weeks |