Evaluate Safety and Effectiveness of XenoSure Biological Patch in the Application of Cardiac Repair

Study Overview
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Brief Summary
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The purpose of this clinical trial is to collect safety and effectiveness data to support cardiac repair indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulations for this kind of device. The clinical trial will be performed solely inside China under GCP regulation and all applicable China regulations on medical device clinical trial.

Detailed Description
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The purpose of this clinical trial is to collect safety and effectiveness data to support cardiac repair indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulations for this kind of device. The clinical trial will be performed solely inside China under GCP regulation and all applicable China regulations on medical device clinical trial. There will be 144 subjects enrolled, including 72 subjects in the trial arm and 72 subjects in the control arm.

Official Title
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Random, Controlled, Single-blinded, Multi-center and Non-inferiority Clinical Study to Evaluate Safety and Effectiveness of XenoSure Biological Patch in the Application of Cardiac Repair

Conditions
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Heart Diseases

Intervention / Treatment
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* Procedure: Open heart surgery to address the heart disease
* Device: Close the defects with XenoSure Patch
* Device: Close the defects with Chest Polyester Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Man or woman aged below 6 years old The expected lifetime of no less than 12 months Patients with congenital heart disease in symptoms of ventricular septal defect, atrial septal defect and tetralogy of fallot who need the surgical repair. Physical conditions and vital signs meet requirements for the surgery. The subjects and/or their guardians sign the written Informed Consent Form. Exclusion Criteria: Patients with severe visceral diseases in liver, kidney, etc. Patients have unstable vital signs and not suitable for the indications. Patients with severe allergic history (especially allergic to bovine materials) Patients with the past medical history of severe immunodeficiency disease The subject has used or plans to use immunomodulatory drugs for more than half a year. The subject with poor blood clotting function, which is defined as that pre-operative INR or APTT is prolonged over 30% than the reference value without drug intervention, or that blood platelet count is less than 100*10^9/L. The subject has severe kidney disorders or diseases with the estimated glomerular filtration rate [GRF]<30mL/min/1.73m2. The subject's ALT or AST level is 2.5 times higher than the upper normal limit or the subject has active liver disease or icterus. The subject has participated in another clinical study within past 3 months or is participating in another clinical study now. The investigator believes that the subject has other reasons unsuitable for inclusion.

Ages Eligible for Study
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Maximum Age: 6 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Arm<br>In Test Arm, the subjects will be implanted with test article - XenoSure patch. The interventions include: Open heart surgery to address the heart disease; Close the defects with XenoSure Patch | Procedure: Open heart surgery to address the heart disease<br>* The patient will first have open heart surgery to achieve access to the diseased site in the heart<br>Device: Close the defects with XenoSure Patch<br>* The heart defects, such as ASD (Atrial Septal Defect) or VSD (Ventricular Septal Defect ), are closed with LeMaitre XenoSure Patch.<br>|
| Active Comparator: Control Arm<br>In Control Arm, the subjects will be implanted with comparator device - Polyester patch by Shanghai Chest Medical Technology Co. The interventions include: Open heart surgery to address the heart disease; Close the defects with Chest Polyester Patch | Procedure: Open heart surgery to address the heart disease<br>* The patient will first have open heart surgery to achieve access to the diseased site in the heart<br>Device: Close the defects with Chest Polyester Patch<br>* The heart defects, such as ASD (Atrial Septal Defect) or VSD (Ventricular Septal Defect ), are closed with a Polyester Patch made by Shanghai Chest Medical Technology Co.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leakage rate at 6 month post-procedure measured by ultrasound | The heart defects should be totally closed by the patch. Any residual flow or leakage, measured by ultrasound, will be recorded. The percentage of the patients that show leakage post-procedure is the failure rate. The study is considered achieved its primary endpoint if the failure rate of the test device is non-inferior to the rate of the comparator device. | 6 months |