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

Summary

A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.

Eligibility

Inclusion 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.

Exclusion Criteria:

* 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.

Conditions12

Locations1 site

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