Status:
RECRUITING
Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts
Lead Sponsor:
Nationwide Children's Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Gunze Limited
Conditions:
HLH - Hypoplastic Left Heart Syndrome
DORV
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.
Detailed Description
This investigation is a prospective, open-labeled clinical trial determining the safety of the use of tissue engineered vascular grafts as conduits for EC TCPC. Patients will be monitored for adverse ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04467671
Start Date
July 15 2020
End Date
August 1 2027
Last Update
June 27 2025
Active Locations (1)
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1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205