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

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ClinicalTrials.gov Identifier: NCT02377674
Recruitment Status : Completed
First Posted : March 3, 2015
Results First Posted : November 10, 2020
Last Update Posted : November 10, 2020
Sponsor:
Collaborator:
Technomics Research
Information provided by (Responsible Party):
Xeltis

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.


Condition or disease Intervention/treatment Phase
Heart Defects, Congenital Device: Vascular Graft, Model COR-VG-001 Not Applicable

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".

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2020

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.




Primary Outcome Measures :
  1. The Number of Graft Related Post-operative Complications That Require a Repeat Surgery or a Non Surgical Treatment Within 12-month Post Implantation. [ Time Frame: 12 months ]
    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 :
  1. The Number of Grafts That Have a Reduced Function Post Operatively. [ Time Frame: 12 months ]
    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.



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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377674


Locations
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Russian Federation
Bakoulev Center of Cardiovascular Surgery
Moscow, Russian Federation, 121552
Sponsors and Collaborators
Xeltis
Technomics Research
Investigators
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Principal Investigator: Leo Bockeria, Professor Bakoulev Center of Cardiovascular Surgery
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Responsible Party: Xeltis
ClinicalTrials.gov Identifier: NCT02377674    
Other Study ID Numbers: XEL-CR-05
First Posted: March 3, 2015    Key Record Dates
Results First Posted: November 10, 2020
Last Update Posted: November 10, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Heart Defects, Congenital
Congenital Abnormalities
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases