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

Primary Purpose

Heart Defects, Congenital

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Vascular Graft, Model COR-VG-001
Sponsored by
Xeltis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Defects, Congenital

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bakoulev Center of Cardiovascular Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vascular Graft, Model COR-VG-001

Arm Description

A surgically implanted vascular graft for pediatric patients undergoing extracardiac total cavopulmonary connection.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
February 18, 2015
Last Updated
October 19, 2020
Sponsor
Xeltis
Collaborators
Technomics Research
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1. Study Identification

Unique Protocol Identification Number
NCT02377674
Brief Title
Safety and Performance of the COR-VG-001 Conduit in Pediatric Patients for Extracardiac Total Cavopulmonary Connection
Acronym
EC-TCPC
Official Title
To Assess the Initial Safety and Performance of COR-VG-001 Conduit in Pediatric Patients Undergoing Extracardiac Total Cavopulmonary Connection (EC-TCPC)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xeltis
Collaborators
Technomics Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Defects, Congenital

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vascular Graft, Model COR-VG-001
Arm Type
Experimental
Arm Description
A surgically implanted vascular graft for pediatric patients undergoing extracardiac total cavopulmonary connection.
Intervention Type
Device
Intervention Name(s)
Vascular Graft, Model COR-VG-001
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Number of Graft Related Post-operative Complications That Require a Repeat Surgery or a Non Surgical Treatment Within 12-month Post Implantation.
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The Number of Grafts That Have a Reduced Function Post Operatively.
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leo Bockeria, Professor
Organizational Affiliation
Bakoulev Center of Cardiovascular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bakoulev Center of Cardiovascular Surgery
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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