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

LeMaitre Vascular

Status: Completed

Conditions: Heart Diseases

Treatments: Device: Close the defects with Chest Polyester Patch; Procedure: Open heart surgery to address the heart disease; Device: Close the defects with XenoSure Patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT03176225

P15077-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 142 patients

Sex: All

Ages: Under 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Man or woman aged below 6 years old
2. The expected lifetime of no less than 12 months
3. Patients with congenital heart disease in symptoms of ventricular septal defect, atrial septal defect and tetralogy of fallot who need the surgical repair.
4. Physical conditions and vital signs meet requirements for the surgery.
5. The subjects and/or their guardians sign the written Informed Consent Form.

Exclusion criteria

1. Patients with severe visceral diseases in liver, kidney, etc.
2. Patients have unstable vital signs and not suitable for the indications.
3. Patients with severe allergic history (especially allergic to bovine materials)
4. Patients with the past medical history of severe immunodeficiency disease
5. The subject has used or plans to use immunomodulatory drugs for more than half a year.
6. 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.
7. The subject has severe kidney disorders or diseases with the estimated glomerular filtration rate [GRF]<30mL/min/1.73m2.
8. 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.
9. The subject has participated in another clinical study within past 3 months or is participating in another clinical study now.
10. The investigator believes that the subject has other reasons unsuitable for inclusion.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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142 participants in 2 patient groups

Test Arm

Experimental group

Description:

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

Treatment:

Device: Close the defects with XenoSure Patch

Procedure: Open heart surgery to address the heart disease

Control Arm

Active Comparator group

Description:

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

Treatment:

Procedure: Open heart surgery to address the heart disease

Device: Close the defects with Chest Polyester Patch