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

• Sponsor: Xeltis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02377674
• Collaborator: Technomics Research (Industry)
• Enrollment: 5
• Location: 1
• Arm: 1
• Duration (Months): 83
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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	N/A

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".

Study Design

• Study Type: Interventional
• 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: Oct 1, 2013
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2020

Arms and Interventions

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.

Outcome Measures

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. [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. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. All arrhythmias as determined by ECG and/or at the investigator's discretion

2. Renal dysfunction as excluded by serum creatinine > ULN and/or urea >ULN and/or at the investigator's discretion

3. Hepatic dysfunction as excluded by ALT >ULN, AST > ULN, GGT > ULN and/or at the investigator's discretion

4. Coagulation disorders as defined by INR outside its normal value, PTT >ULN and Fibrinogen <LLN and/or at the investigator's discretion

5. Transcutaneous O2 saturation < 65% and/or at the investigator's discretion

6. Immunodeficiency

7. Trisomia 21

8. Asplenia as determined by abdominal ultrasound

9. Heterotaxia as determined by abdominal ultrasound

10. HIV-infection

11. Syphilis (Treponema pallidum)

12. Hepatitis-B and/or -C virus infection

13. Unwillingness of Parental/legal guardian to give consent

14. Contraindications on ethical grounds

15. Treatment with other investigational products

16. Known or suspected non-compliance, drug or alcohol abuse of the parents/legal guardian

17. Inability of the parents/legal guardian to follow the procedures of the study, e.g. due to language problems

18. Participation of the patient in another study within 30 days preceding and during the present study

19. Previous enrollment of the patient into the current study

20. Enrollment of the investigator's family members, employees and other dependent persons

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bakoulev Center of Cardiovascular Surgery	Moscow		Russian Federation	121552

Sponsors and Collaborators

• Xeltis
• Technomics Research

Investigators

• Principal Investigator: Leo Bockeria, Professor, Bakoulev Center of Cardiovascular Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xeltis
• ClinicalTrials.gov Identifier: NCT02377674
• Other Study ID Numbers: XEL-CR-05
• First Posted: Mar 3, 2015
• Last Update Posted: Nov 10, 2020
• Last Verified: Oct 1, 2020

• Additional relevant MeSH terms: Heart Defects, Congenital; Congenital Abnormalities

Study Results

Participant Flow

Arm/Group Title	Vascular Graft, Model COR-VG-001
Arm/Group Description	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.
Period Title: Overall Study
STARTED	5
COMPLETED	5
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Vascular Graft, Model COR-VG-001
Arm/Group Description	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.
Overall Participants	5
Age (Count of Participants)
<=18 years	5 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	6.2
Sex: Female, Male (Count of Participants)
Female	2 40%
Male	3 60%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Russia	5 100%

Outcome Measures

1. Primary Outcome

Title	The Number of Graft Related Post-operative Complications That Require a Repeat Surgery or a Non Surgical Treatment Within 12-month Post Implantation.
Description	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
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vascular Graft, Model COR-VG-001
Arm/Group Description	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.
Measure Participants	5
Count of Participants [Participants]	0 0%

2. Secondary Outcome

Title	The Number of Grafts That Have a Reduced Function Post Operatively.
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vascular Graft, Model COR-VG-001
Arm/Group Description	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.
Measure Participants	5
Count of Participants [Participants]	1 20%

Adverse Events

Arm/Group Title	Vascular Graft, Model COR-VG-001
Arm/Group Description	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.
All Cause Mortality
	Vascular Graft, Model COR-VG-001
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Serious Adverse Events
	Vascular Graft, Model COR-VG-001
	Affected / at Risk (%)	# Events
Total	4/5 (80%)
Cardiac disorders
Cardiac Failure, poly seriositis NYHA III	1/5 (20%)	1
Decreased LVEF	1/5 (20%)	2
Infections and infestations
Left Lower Lobe Pneumonia	1/5 (20%)	1
Product Issues
Stenosis of Conduit	1/5 (20%)	1
Respiratory, thoracic and mediastinal disorders
Pleural Effusion Caused by Cardiac Failure	2/5 (40%)	3
Other (Not Including Serious) Adverse Events
	Vascular Graft, Model COR-VG-001
	Affected / at Risk (%)	# Events
Total	4/5 (80%)
Cardiac disorders
Sick Sinus Syndrome	1/5 (20%)	1
Bundle Branch Block Onset	1/5 (20%)	1
Decreased Ejection Fraction	1/5 (20%)	1
Low Stroke Volume in the IVC and Conduit	1/5 (20%)	1
Mild Stenosis In Conduit	1/5 (20%)	1
Reduced Maximum Systolic Velocity	1/5 (20%)	1
Infections and infestations
Cold	2/5 (40%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Researchers engaged in Project can present research results provided the Sponsor has been furnished copies at least one month in advance of the submission. Sponsor shall have thirty (30) days, after receipt of said copies, to object because there is confidential subject matter or proprietary information of Sponsor which needs protection. In the event that Sponsor makes such objection, said Researcher(s) shall refrain from making such publication or presentation for a maximum of six months