Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts — TEVG-2  

Cardiovascular Diseases Clinical Trial

Official title: 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.

Status Recruiting

Clinical Trial Summary

A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.

Clinical Trial 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 events (AE) and serious adverse events (SAE). Special attention will be paid to the incidence of stenosis. We will determine graft-related morbidity and mortality for the second generation TEVGs which will include any post-operative complication such as any aneurismal dilation, stenosis, thromboembolic or infectious event that requires treatment and is thought to be caused by the graft as determined by the investigators and confirmed by the data safety monitoring board. The graft related complication rates will be compared between the first and second generation TEVGs. An interim analysis will be performed to assess the incidence of early (<6 month) graft-related complications in the first 6 enrolled patients. Safety and tolerability will be assessed through serial imaging, to determine the effect of growth and remodeling on graft performance through echocardiography and 4-dimensional MRI. All appropriate patients requiring EC TCPC who meet study inclusion/exclusion criteria will be evaluated for enrollment in the clinical trial. All enrolled subjects will be required to have follow-up visits at Nationwide Children's Hospital for a minimum of 2 years following implant. After obtaining informed consent for the patient's parents, patients with single ventricle cardiac anomalies will undergo EC TCPC using a tissue engineered conduit. Post-operative care and monitoring will follow an established, standardized, clinical algorithm in which the patient's clinical status including complications and measurements of graft function will be serially evaluated and recorded over a two year period using physical examination, echocardiography, and MRI. ;

Related Conditions & MeSH terms

• Cardiovascular Abnormalities
• Cardiovascular Diseases
• Congenital Abnormalities
• DILV - Double Inlet Left Ventricle
• DORV
• Heart Defects, Congenital
• Heart Diseases
• HLH - Hypoplastic Left Heart Syndrome
• Hypoplastic Left Heart Syndrome
• Mitral Atresia
• Single-ventricle
• Tricuspid Atresia
• Unbalanced AV Canal
• Univentricular Heart

• NCT number: NCT04467671
• Study type: Interventional
• Source: Nationwide Children's Hospital
• Contact: Samantha Fichtner, BSN, RN
• Phone: 614-355-5764
• Email: samantha.fichtner@nationwidechildrens.org
• Status: Recruiting
• Phase: Phase 2
• Start date: July 15, 2020
• Completion date: August 2027