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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Arm | Experimental | 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 |
|
| Control Arm | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open heart surgery to address the heart disease | Procedure | The patient will first have open heart surgery to achieve access to the diseased site in the heart |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
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| Close the defects with XenoSure Patch | Device | The heart defects, such as ASD (Atrial Septal Defect) or VSD (Ventricular Septal Defect ), are closed with LeMaitre XenoSure Patch. |
|
| Close the defects with Chest Polyester Patch | Device | 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. |
|
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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