Clinical Trial

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

Study acronym: TEVG-2
Recruiting Phase 2
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Summary
A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2020-07-08; most recent amendment 2025-06-24.
Trial Details
NCT Number NCT04467671
Lead Sponsor Nationwide Children's Hospital
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Gunze Limited, National Institutes of Health (NIH)
Conditions HLH - Hypoplastic Left Heart Syndrome, DORV, DILV - Double Inlet Left Ventricle, Mitral Atresia, Tricuspid Atresia, Unbalanced AV Canal, Single-ventricle, Heart Defects, Congenital +3 more
Enrollment 24 participants
Start Date 2020-07-15
Primary Completion 2026-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2025-06-27