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
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|
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".
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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.
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
|Bakoulev Center of Cardiovascular Surgery|
|Moscow, Russian Federation, 121552|
|Principal Investigator:||Leo Bockeria, Professor||Bakoulev Center of Cardiovascular Surgery|