- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03176225
Evaluate Safety and Effectiveness of XenoSure Biological Patch in the Application of Cardiac Repair
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
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100853
- Recruiting
- Chinese PLA General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
The patient will first have open heart surgery to achieve access to the diseased site in the heart
The heart defects, such as ASD (Atrial Septal Defect) or VSD (Ventricular Septal Defect ), are closed with LeMaitre XenoSure Patch.
|
Active Comparator: 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
|
The patient will first have open heart surgery to achieve access to the diseased site in the heart
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Leakage rate at 6 month post-procedure measured by ultrasound
Time Frame: 6 months
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P15077-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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