At a glance
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To Assess the Initial Safety and Performance of COR-VG-001 Conduit in Pediatric Patients Undergoing Extracardiac Total Cavopulmonary Connection (EC-TCPC)
In Brief
A clinical study evaluating Vascular Graft, Model COR-VG-001 for Heart Defects, Congenital. Completed, enrolled 5 participants across 1 site.
Detailed Summary
The extracardiac Fontan surgery/procedure involves diverting the venous blood from the inferior vena cava to the pulmonary arteries without passing through the morphologic right ventricle. In the extracardiac conduit type of Fontan, one end of a synthetic tube graft is connected to the inferior vena cava and the other end to the pulmonary artery confluence. Xeltis developed a biodegradable prosthesis, the Xeltis Vascular Graft Model COR-VG-001, to be used as an extracardiac conduit between right atrium and the pulmonary arteries. The prosthesis is immediately mechanically functional, while its physiochemical characteristics should enable cell infiltration and tissue formation. The Xeltis Vascular Graft Model COR-VG-OO is specifically designed to enhance the Fontan surgery outcome by reducing synthetic material related complications and improving hemodynamic characteristics.
Study Details
Timeline
Interventions
The intended use of the Xeltis Vascular Graft, Model COR-VG-001 is to create an extracardiac total cavopulmonary connection (EC-TCPC) connection to divert the venous blood from the inferior vena cava to the pulmonary arteries without passing through the morphologic right ventricle reducing the volume load on the functional single ventricle and thereby improving hemodynamics by minimizing the deleterious effects of ventricular hypertrophy.