Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts

Eligibility Criteria

• * Patients will be eligible for inclusion in the study if they meet all of the following criteria.
• 1. Patient must be a candidate to undergo an extracardiac total cavopulmonary connection.
• 2. 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.
• 1. Patient has an urgent/emergent operative status.
• 2. Patient has acute renal failure or renal insufficiency in the opinion of the investigator
• 3. Patient requires a graft less than 12 mm or greater than 24 mm in diameter.
• 4. Patient has a pacemaker.
• 5. Patient has pulmonary vascular resistance greater than 4 um2 (u=Wood's units)
• 6. Patient has abnormal venous drainage (interrupted inferior vena cava \[IVC\]).
• 7. Patient presents with significant atrio-ventricular valve regurgitation that in the opinion of the investigator, makes them ineligible.
• 8. Patient has a history of another condition or significant medical problem that, in the opinion of the investigator, precludes compliance with protocol-specified procedures.
• 9. Patients taking any medications that in the opinion of the Investigator could interfere with the TEVG, including bisphosphonates (i.e. Clodronate or Zoledronate).
• 10. Patient or parent/legal guardian is, in the opinion of the investigator, unable to comply with protocol evaluations.
• 11. Preoperative hemoglobin \<11.0 mg/dL at time of patient's pre-admission testing.