A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.
Patients will be eligible for inclusion in the study if they meet all of the following criteria.
Patient must be a candidate to undergo an extracardiac total cavopulmonary connection.
Patient and/or legal guardian must voluntarily provide informed consent/assent for participation in the study.
Patients will be excluded from participation in the study if they meet any of the following criteria.
Patient has an urgent/emergent operative status.
Patient has acute renal failure or renal insufficiency in the opinion of the investigator
Patient requires a graft less than 12 mm or greater than 24 mm in diameter.
Single group
Tissue Engineered Vascular Grafts
Combination productPatients will undergo EC TCPC interposition grafting with a tissue engineered vascular graft and serial magnetic resonance imaging (MRI)
Safety and Tolerability of TEVG
Assessed through graft related complications as determined by serial echocardiogram
Safety and Tolerability of TEVG
Assessed through graft related complications as determined by serial MRI
Safety and Tolerability of TEVG
Assessed through adverse events
Efficacy of TEVG
Evaluate graft performance based on MRI
Efficacy of TEVG
Measured graft volume(mL) as determined by MRI
Efficacy of TEVG
Measured graft length (mm) as determined by MRI
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Nationwide Children's Hospital
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Gunze Limited
Collaborator
National Institutes of Health (NIH)
Collaborator
