A tissue engineered vascular graft as the conduit in single-ventricle heart surgery

You may qualify if

• 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.

You can't join if

• 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.; Patient has a pacemaker.; Patient has pulmonary vascular resistance greater than 4 um2 (u=Wood's units); Patient has abnormal venous drainage (interrupted inferior vena cava [IVC]).; Patient presents with significant atrio-ventricular valve regurgitation that in the opinion of the investigator, makes them ineligible.; Patient has a history of another condition or significant medical problem that, in the opinion of the investigator, precludes compliance with protocol-specified procedures.; Patients taking any medications that in the opinion of the Investigator could interfere with the TEVG, including bisphosphonates (i.e. Clodronate or Zoledronate).; Patient or parent/legal guardian is, in the opinion of the investigator, unable to comply with protocol evaluations.; Preoperative hemoglobin <11.0 mg/dL at time of patient's pre-admission testing.