Safety and Performance of a Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis

Study Overview
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Brief Summary
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Xeltis developed biodegradable patch prosthesis, the Vascular Patch Model COR-VP-001, to be used as a vascular patch to augment the pulmonary trunk and 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-VP-001 is specifically designed to improve surgical outcomes by reducing synthetic material related complications and improving hemodynamic characteristics.

Detailed Description
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Xeltis has developed a medical device for treating pediatric cardiovascular patients requiring RVOT reconstruction. Xeltis' mission is to offer 'Solutions for a Lifetime' to cardiovascular patients. Xeltis has developed a unique technology based on novel biodegradable bio-materials allowing the regrowth of natural heart valves or blood vessels in patients' bodies from their own cells. The principle of Xeltis' COR technology (COR stands for Cardiovascular Organ Regeneration) is to implant a biodegradable prosthesis of a blood vessels that is shaped like the part to be replaced. The prosthesis is immediately mechanically functional, while its physiochemical characteristics should enable cell infiltration and tissue formation. Tissue is regenerated and functional by the time the polymer is biodegraded.

Official Title
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Initial Safety and Performance of the COR-VP-001 Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis

Conditions
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Heart Defects, Congenital

Intervention / Treatment
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* Device: Xeltis Vascular Patch, Model COR-VP-001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient requiring a bidirectional cava-pulmonary anastomosis Male or Female Age: 2 months to 16 years Exclusion Criteria: Main Exclusion Criteria Arrhythmias as determined by ECG and/or at the investigator's discretion Other clinically significant malformations Coagulation disorders as defined by INR outside its normal value, PTT >ULN and Fibrinogen <LLN and/or at the investigator's discretion HIV-infection Syphilis (Treponema pallidum) Hepatitis-B and/or -C virus infection Unwillingness of Parental/legal guardian to give consent Treatment with other investigational products Known or suspected noncompliance, 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 enrolment of the patient into the current study Enrolment of the investigator's family members, employees and other dependent persons

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xeltis Vascular Patch, Model COR-VP-001<br>Patients implanted with the vascular patch during staged bidirectional cava-pulmonary anastomosis. | Device: Xeltis Vascular Patch, Model COR-VP-001<br>* The intended use of the Xeltis Vascular Patch, Model COR-VP-001 is to augment pulmonary artery and thereby improve hemodynamics by increasing blood flow to the lungs in patients with congenital pulmonary artery obstructions as an initial part of the staged procedure of a bidirectional cava-pulmonary anastomosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Patch Related Serious Adverse Events. | Evaluation of the safety of the COR-VP-001 as defined by number of patients having patch related post-operative complications requiring surgery, intervention or leading to death up to 12 months post implantation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Loss of Functionality of the Patch. | Evaluation of the performance of the COR-VP-001 by analyzing the incidence of loss of functionality requiring intervention within up to 12 months post implantation. | 12 months | 
| Histological Evaluation | Number of patients with histological evaluation of the patch material obtained during the planned reoperation within up to 12 months after implantation | up to 12 Months after Implant |