Evaluate Safety and Effectiveness of XenoSure Biological Patch in the Application of Cardiac Repair
NCT ID: NCT03176225
Last Updated: 2025-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
142 participants
INTERVENTIONAL
2017-08-15
2024-02-15
Brief Summary
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Detailed Description
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There will be 144 subjects enrolled, including 72 subjects in the trial arm and 72 subjects in the control arm.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Test Arm
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
Open heart surgery to address the heart disease
The patient will first have open heart surgery to achieve access to the diseased site in the heart
Close the defects with XenoSure Patch
The heart defects, such as ASD (Atrial Septal Defect) or VSD (Ventricular Septal Defect ), are closed with LeMaitre XenoSure Patch.
Control Arm
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
Open heart surgery to address the heart disease
The patient will first have open heart surgery to achieve access to the diseased site in the heart
Close the defects with Chest Polyester Patch
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.
Interventions
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Open heart surgery to address the heart disease
The patient will first have open heart surgery to achieve access to the diseased site in the heart
Close the defects with XenoSure Patch
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
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
6 Years
ALL
No
Sponsors
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LeMaitre Vascular
INDUSTRY
Responsible Party
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Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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P15077-1
Identifier Type: -
Identifier Source: org_study_id
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