Safety and Performance of the COR-VG-001 Conduit in Pediatric Patients for Extracardiac Total Cavopulmonary Connection

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Heart Defects, Congenital

Intervention / Treatment
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* Device: Vascular Graft, Model COR-VG-001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient requiring EC-TCPC Male or Female Aged ≥ 2 years Exclusion Criteria: Pulmonary artery pressure (PAP) > 15 mm Hg as excluded by angiography/cardiac catheterization Pulmonary vascular resistance (PVR) >3 Wood units as excluded by angiography/cardiac catheterization Moderate or severe atrioventricular (AV) valve regurgitation requiring correction, as determined by echocardiography and/or angiography Moderate or severe outflow valve regurgitation requiring correction as determined by echocardiography and/or angiography Outflow tract (aortic arch and isthmus) obstruction as excluded by: a residual outflow gradient of ≥ 20mm Hg or requirement of corrective surgery as determined by echocardiography and/ or angiography All arrhythmias as determined by ECG and/or at the investigator's discretion Renal dysfunction as excluded by serum creatinine > ULN and/or urea >ULN and/or at the investigator's discretion Hepatic dysfunction as excluded by ALT >ULN, AST > ULN, GGT > ULN and/or at the investigator's discretion Coagulation disorders as defined by INR outside its normal value, PTT >ULN and Fibrinogen <LLN and/or at the investigator's discretion Transcutaneous O2 saturation < 65% and/or at the investigator's discretion Immunodeficiency Trisomia 21 Asplenia as determined by abdominal ultrasound Heterotaxia as determined by abdominal ultrasound HIV-infection Syphilis (Treponema pallidum) Hepatitis-B and/or -C virus infection Unwillingness of Parental/legal guardian to give consent Contraindications on ethical grounds Treatment with other investigational products Known or suspected non-compliance, drug or alcohol abuse of the parents/legal guardian Inability of the parents/legal guardian to follow the procedures of the study, e.g. due to language problems Participation of the patient in another study within 30 days preceding and during the present study Previous enrollment of the patient into the current study Enrollment of the investigator's family members, employees and other dependent persons

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vascular Graft, Model COR-VG-001<br>A surgically implanted vascular graft for pediatric patients undergoing extracardiac total cavopulmonary connection. | Device: Vascular Graft, Model COR-VG-001<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Graft Related Post-operative Complications That Require a Repeat Surgery or a Non Surgical Treatment Within 12-month Post Implantation. | Evaluation of the safety of the COR-VG-001 as defined by numbers of patients having graft related post-operative complications requiring surgery, intervention or leading to death within 12-month post implantation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Grafts That Have a Reduced Function Post Operatively. | Evaluation of the performance of the COR-VG-01 by analyzing, with the help of echocardiography, the incidence of loss of functionality requiring intervention within 12 months post implantation. | 12 months |