Two-Year Phase 2 Study of Safety and Effectiveness of Second-Generation Tissue Engineered Vascular Grafts for Extracardiac Total Cavopulmonary Connection in Children with Heart Defects

What this Trial Is About

Researchers are evaluating the safety and effectiveness of second-generation tissue engineered vascular grafts TEVGs used as conduits for extracardiac total cavopulmonary connection EC TCPC in patients with single ventricle heart defects. This open-label, single-arm clinical trial focuses on monitoring adverse events, graft-related complications such as stenosis, aneurysmal dilation, thromboembolic or infectious events, and comparing complication rates with first-generation TEVGs. An interim analysis will assess early complications in the first six patients. Participants will undergo EC TCPC surgery using the second-generation TEVG as a conduit. After surgery, patients will be followed for at least two years with regular visits at Nationwide Childrens Hospital. During this time, researchers will use serial imaging techniques including echocardiography and 4-dimensional MRI to monitor graft performance, growth, and remodeling. Throughout the study, patients will have their clinical status and graft function regularly evaluated through physical exams, imaging, and record keeping. Researchers will assess safety and tolerability over two years and track efficacy outcomes. The study includes careful monitoring for postoperative complications and requires informed consent from patients or their legal guardians before enrollment.

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