Trial Outcomes & Findings for Safety and Performance of the COR-VG-001 Conduit in Pediatric Patients for Extracardiac Total Cavopulmonary Connection (NCT NCT02377674)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

12 months

Results posted on

2020-11-10

Participant Flow

Participant milestones

Participant milestones
Measure	Vascular Graft, Model COR-VG-001 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 Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vascular Graft, Model COR-VG-001 n=5 Participants 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.
Age, Categorical <=18 years	5 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	6.2 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment Russia	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Vascular Graft, Model COR-VG-001 n=5 Participants 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.
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

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vascular Graft, Model COR-VG-001 n=5 Participants 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.
The Number of Grafts That Have a Reduced Function Post Operatively.	1 Participants

Adverse Events

Vascular Graft, Model COR-VG-001

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vascular Graft, Model COR-VG-001 n=5 participants at risk 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.
Infections and infestations Left Lower Lobe Pneumonia	20.0% 1/5 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pleural Effusion Caused by Cardiac Failure	40.0% 2/5 • Number of events 3
Cardiac disorders Cardiac Failure, poly seriositis NYHA III	20.0% 1/5 • Number of events 1
Product Issues Stenosis of Conduit	20.0% 1/5 • Number of events 1
Cardiac disorders Decreased LVEF	20.0% 1/5 • Number of events 2

Other adverse events

Other adverse events
Measure	Vascular Graft, Model COR-VG-001 n=5 participants at risk 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.
Cardiac disorders Sick Sinus Syndrome	20.0% 1/5 • Number of events 1
Cardiac disorders Bundle Branch Block Onset	20.0% 1/5 • Number of events 1
Cardiac disorders Decreased Ejection Fraction	20.0% 1/5 • Number of events 1
Cardiac disorders Low Stroke Volume in the IVC and Conduit	20.0% 1/5 • Number of events 1
Infections and infestations Cold	40.0% 2/5 • Number of events 2
Cardiac disorders Mild Stenosis In Conduit	20.0% 1/5 • Number of events 1
Cardiac disorders Reduced Maximum Systolic Velocity	20.0% 1/5 • Number of events 1

Additional Information

Eliane Schutte, CEO

Xeltis

Phone: +31 40 751 7614

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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
Publication restrictions are in place

Restriction type: OTHER