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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Leakage rate at 6 month post-procedure measured by ultrasound
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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/1.73m
- •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.
结局指标
主要结局
Leakage rate at 6 month post-procedure measured by ultrasound
时间窗: 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.
次要结局
未报告次要终点