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

To Assess the Initial Safety and Performance of COR-VG-001 Conduit in Pediatric Patients Undergoing Extracardiac Total Cavopulmonary Connection (EC-TCPC)

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 Overview

• Status: Completed
• Conditions: Heart Defects, Congenital
• Intervention / Treatment: Device: Vascular Graft, Model COR-VG-001

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".

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 121552
    • Bakoulev Center of Cardiovascular Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient requiring EC-TCPC
2. Male or Female
3. Aged ≥ 2 years

Exclusion Criteria:

1. Pulmonary artery pressure (PAP) > 15 mm Hg as excluded by angiography/cardiac catheterization
2. Pulmonary vascular resistance (PVR) >3 Wood units as excluded by angiography/cardiac catheterization
3. Moderate or severe atrioventricular (AV) valve regurgitation requiring correction, as determined by echocardiography and/or angiography
4. Moderate or severe outflow valve regurgitation requiring correction as determined by echocardiography and/or angiography

5. 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
6. All arrhythmias as determined by ECG and/or at the investigator's discretion
7. Renal dysfunction as excluded by serum creatinine > ULN and/or urea >ULN and/or at the investigator's discretion
8. Hepatic dysfunction as excluded by ALT >ULN, AST > ULN, GGT > ULN and/or at the investigator's discretion
9. Coagulation disorders as defined by INR outside its normal value, PTT >ULN and Fibrinogen <LLN and/or at the investigator's discretion
10. Transcutaneous O2 saturation < 65% and/or at the investigator's discretion
11. Immunodeficiency
12. Trisomia 21
13. Asplenia as determined by abdominal ultrasound
14. Heterotaxia as determined by abdominal ultrasound
15. HIV-infection
16. Syphilis (Treponema pallidum)
17. Hepatitis-B and/or -C virus infection
18. Unwillingness of Parental/legal guardian to give consent
19. Contraindications on ethical grounds
20. Treatment with other investigational products
21. Known or suspected non-compliance, drug or alcohol abuse of the parents/legal guardian
22. Inability of the parents/legal guardian to follow the procedures of the study, e.g. due to language problems
23. Participation of the patient in another study within 30 days preceding and during the present study
24. Previous enrollment of the patient into the current study
25. Enrollment of the investigator's family members, employees and other dependent persons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Vascular Graft, Model COR-VG-001; A surgically implanted vascular graft for pediatric patients undergoing extracardiac total cavopulmonary connection.

Device: Vascular Graft, Model COR-VG-001; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xeltis
• Collaborators: Technomics Research
• Investigators: Principal Investigator: Leo Bockeria, Professor, Bakoulev Center of Cardiovascular Surgery

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: February 18, 2015
• First Submitted That Met QC Criteria: February 24, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: XEL-CR-05