Safety and Performance of the COR-VG-001 Conduit in Pediatric Patients for Extracardiac Total Cavopulmonary Connection
Condition: Heart Defects, Congenital
MeSH terms: Heart Defects, Congenital; Congenital Abnormalities
Study type: Interventional

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.
    

Detailed description: 
      Although significant progress has been made in recent years in the field of congenital heart
      disease treatment, a substantial unmet clinical need remains for implantable
      materials/devices such as vascular grafts and heart valves with improved long-term
      performance and reduced device-related complications.

      To address these limitations new generation of biodegradable polymers using recent advances
      in supramolecular chemistry have been developed to create highly porous vascular grafts
      allowing efficient cell infiltration following by gradual replacement of the polymer material
      with the patient's own native-like vascular tissue resulting in full functional restoration.
      In addition to the ability of reducing postoperative graft-related complications such types
      of implants have a potential to grow to adapt to the overall body growth and therefore may
      represent a completely new modality for the treatment of congenital heart disease. In
      contrast to today's situation with synthetic non-absorbable vascular grafts considered as a
      "standard of care", where the pediatric patients have to be re-operated several times to
      adjust the prosthesis size to the somatic growth of the child associated with substantial
      morbidity and mortality and requiring prolonged anticoagulation treatment, a biodegradable
      polymer implant could represent a "one-time solution".
    

Intervention name(s): Vascular Graft, Model COR-VG-001
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment