Evaluate Safety and Effectiveness of XenoSure Biological Patch in the Application of Cardiac Repair
Primary Purpose
Heart Diseases
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Open heart surgery to address the heart disease
Close the defects with XenoSure Patch
Close the defects with Chest Polyester Patch
Sponsored by
About this trial
This is an interventional treatment trial for Heart Diseases
Eligibility Criteria
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.
Sites / Locations
- Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test Arm
Control Arm
Arm 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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03176225
Brief Title
Evaluate Safety and Effectiveness of XenoSure Biological Patch in the Application of Cardiac Repair
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
November 15, 2025 (Anticipated)
Study Completion Date
February 15, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LeMaitre Vascular
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test Arm
Arm Type
Experimental
Arm 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
Arm Title
Control Arm
Arm Type
Active Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Open heart surgery to address the heart disease
Intervention Description
The patient will first have open heart surgery to achieve access to the diseased site in the heart
Intervention Type
Device
Intervention Name(s)
Close the defects with XenoSure Patch
Intervention Description
The heart defects, such as ASD (Atrial Septal Defect) or VSD (Ventricular Septal Defect ), are closed with LeMaitre XenoSure Patch.
Intervention Type
Device
Intervention Name(s)
Close the defects with Chest Polyester Patch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Leakage rate at 6 month post-procedure measured by ultrasound
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vic Zhang
Phone
781-425-1729
Email
xzhang@lemaitre.com
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vic Zhang
Phone
7814251729
Email
xzhang@lemaitre.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluate Safety and Effectiveness of XenoSure Biological Patch in the Application of Cardiac Repair
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