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

NCT02377674 | Completed Results

• 1 other identifier: XEL-CR-05
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Defects, Congenital

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The Number of Grafts That Have a Reduced Function Post Operatively.

  12 months

Study Arms (1)

Vascular Graft, Model COR-VG-001

EXPERIMENTAL

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

Device: Vascular Graft, Model COR-VG-001

Interventions

Vascular Graft, Model COR-VG-001 DEVICE

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.

Vascular Graft, Model COR-VG-001

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient requiring EC-TCPC
• Male or Female
• Aged ≥ 2 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Xeltis: lead
• Technomics Research: collaborator

Study Sites (1)

Bakoulev Center of Cardiovascular Surgery

Moscow, 121552, Russia

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Vascular Grafting

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Eliane Schutte, CEO
• Organization: Xeltis

clinical@xeltis.com

+31 40 751 7614

Study Officials

• Leo Bockeria, Professor

  Bakoulev Center of Cardiovascular Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: March 3, 2015
• Study Start: October 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2020
• Last Updated: November 10, 2020
• Results First Posted: November 10, 2020

Record last verified: 2020-10

Locations

RU (1)