N/A
N=5
Safety and Performance of the COR-VG-001 Conduit in Pediatric Patients for Extracardiac Total Cavopulmonary Connection
Heart Defects, Congenital
Bottom Line
View on ClinicalTrials.gov: NCT02377674 ↗Enrolled (actual)
5
Serious AEs
80.0%
Results posted
Nov 2020
Primary outcome: Primary: The Number of Graft Related Post-operative Complications That Require a Repeat Surgery or a Non Surgical Treatment Within 12-month Post Implantation. — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vascular Graft, Model COR-VG-001 (Device)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- Xeltis
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Graft Related Post-operative Complications That Require a Repeat Surgery or a Non Surgical Treatment Within 12-month Post Implantation. |
— | — |
| SECONDARY The Number of Grafts That Have a Reduced Function Post Operatively. |
1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02377674). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.