Actively Recruiting
Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts
Led by Nationwide Children's Hospital · Updated on 2025-06-27
24
Participants Needed
1
Research Sites
367 weeks
Total Duration
On this page
Sponsors
N
Nationwide Children's Hospital
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.
CONDITIONS
Official Title
Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Patient has an urgent/emergent operative status.
- Patient has acute renal failure or renal insufficiency as determined by 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 Wood's units.
- Patient has abnormal venous drainage (interrupted inferior vena cava).
- Significant atrio-ventricular valve regurgitation making them ineligible in the investigator's opinion.
- History of another condition or significant medical problem that precludes compliance with protocol procedures as per investigator.
- Taking medications that could interfere with TEVG, including bisphosphonates (e.g., Clodronate or Zoledronate).
- Patient or parent/legal guardian unable to comply with protocol evaluations as judged by the investigator.
- Preoperative hemoglobin less than 11.0 mg/dL at pre-admission testing.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
Research Team
S
Samantha Fichtner, BSN, RN
CONTACT
V
Victoria Shay
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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