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

Launched by NATIONWIDE CHILDREN'S HOSPITAL · Jul 8, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new type of artificial blood vessel, called a second-generation tissue-engineered vascular graft (TEVG), to see how safe and effective it is for children and young adults who need a specific heart surgery known as extracardiac total cavopulmonary connection. This surgery is often required for patients with various congenital heart defects, including conditions like Hypoplastic Left Heart Syndrome and Tricuspid Atresia.

To participate in this study, patients must be scheduled for this heart surgery and have their parent or legal guardian agree to take part in the trial. However, some patients may not qualify due to certain health issues, such as having an urgent medical condition or specific heart problems. Those who join the study can expect to be closely monitored for their health and the performance of the new graft over two years. This research aims to improve treatment options for young patients with serious heart conditions, and all participants will receive care and attention tailored to their needs throughout the study.

Gender

ALL

Eligibility criteria

• 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.