This trial is active, not recruiting.

Condition heart defects, congenital
Treatment vascular graft, model cor-vg-001
Sponsor Xeltis AG
Collaborator Technomics Research
Start date October 2013
End date September 2015
Trial size 5 participants
Trial identifier NCT02377674, XEL-CR-05


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
A surgically implanted vascular graft for pediatric patients undergoing extracardiac total cavopulmonary connection.
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 Outcomes

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

Secondary Outcomes

The number of grafts that have a reduced function post operatively.
time frame: 12 months

Eligibility Criteria

Male or female participants from 2 years up to 18 years old.

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

Additional Information

Official title To Assess the Initial Safety and Performance of COR-VG-001 Conduit in Pediatric Patients Undergoing Extracardiac Total Cavopulmonary Connection (EC-TCPC)
Principal investigator Leo Bockeria, Professor
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".
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Xeltis AG.