Heart Diseases
Conditions
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.
Interventions
PROCEDUREOpen 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
DEVICEClose 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.
DEVICEClose 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.
Sponsors
LeMaitre Vascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leakage rate at 6 month post-procedure measured by ultrasound | 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. |
Countries
China
Outcome results
None listed