Prospective, Open-labeled, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of the Second-generation Tissue Engineered Vascular Graft as Vascular Conduits for Extracardiac Total Cavopulmonary Connection.
Who is this study for? Patients with Hypoplastic Left Heart Syndrome, Congential Heart Defects
What treatments are being studied? Tissue Engineered Vascular Grafts
Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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.
Locations
United States
Ohio
Nationwide Children's Hospital
RECRUITING
Columbus
Contact Information
Primary
Samantha Fichtner, BSN, RN
samantha.fichtner@nationwidechildrens.org
614-355-5764
Backup
Victoria Shay
victoria.shay@nationwidechildrens.org
Time Frame
Start Date: 2020-07-15
Estimated Completion Date: 2027-08
Participants
Target number of participants: 24
Treatments
Experimental: Tissue Engineered Vascular Grafts
Related Therapeutic Areas
Sponsors
Collaborators: Gunze Limited, National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Leads: Nationwide Children's Hospital