Chinese Academy of Medical Sciences, Fuwai Hospital
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 108
- 试验地点
- 4
- 主要终点
- success rate of occlusion at 6 months after the surgery
研究概览
简要总结
The purpose of this clinical trial is to verify the safety and effectiveness of the Fully Absorbable VSD Occlusion System and VSD Occlusion System produced by Shanghai shape memory alloy materials co., LTD. Clinical trials are designed as prospective, multicenter, randomized controlled, noninferiority clinical trials. Prospective randomized multicenter trial involving about 108 subjects will be enrolled in 4 centers. Patients will be randomized to two groups in equal proportion (54 in each). The success rate of occlusion at 6 months after operation is the main evaluation index in this clinical trial.
详细描述
- This is a prospective, multicenter, randomized and noninferiority clinical trial, which is designed to compare the effectiveness and safety with the fully absorbable ventricular septal defect (VSD) occlusion system and VSD occlusion system produced by Shanghai shape memory alloy materials co., LTD.
- This trial will recruit about 108 subjects from 4 centers. Patients will be randomized to two groups in equal proportion (54 in each). The proposal recruiting period is 12 months and the follow-up will be performed at 1 month, 3 months and 6 months after surgery.
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
- None
入排标准
- 年龄范围
- 1 Year 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects and/or their legal guardians will be informed of the nature of this study and agree to participate in this clinical trial in accordance with all terms of this study.Signed the informed consent approved by the ethics committee, agreed to accept the postoperative treatment program, and completed the follow-up and related examinations as required by the follow-up;
- •Aged from 1 to 60 years old, weight more than 10 kg, male or non-pregnant women;
- •VSD effective shunt ≥3mm, ≤14mm;
- •Distance between the edge of defect and the right aortic valve is more than 3mm, no aortic valve prolapse or moderate aortic regurgitation.
排除标准
- •Irreversible pulmonary vascular disease;Severe pulmonary hypertension with bidirectional shunt;
- •Bleeding disorders or known clotting disorders (including heparin-induced thrombocytopenia),contraindications to antiplatelet therapy, or rejection of transfusions;
- •Sepsis or severe infection within 1 month prior to occlusion;
- •Patients with thrombosis at the occluder placement and venous thrombosis at the catheter insertion site;
- •Cardiac malformation dependent on ventricular septal defect (VSD);
- •Not suitable for treatment with this product.
研究组 & 干预措施
Treatment Group
Experimental group is allocated to use novel fully degradable ventricular septal defect closure system manufactured by Shanghai shape memory alloy materials co. LTD.
干预措施: Fully Absorbable VSD Occlusion System (Device)
Control Group
Control Group is allocated to use Interposition conveying device for ventricular septal defect closure produced by Shanghai shape memory alloy material co. LTD.
干预措施: VSD Occluder (Device)
结局指标
主要结局
success rate of occlusion at 6 months after the surgery
时间窗: 6 months after the surgery
Successful occlusion is that when follow-up under echocardiography at 6 months after surgery, the occlusion site shows no residual shunt or only a small amount of residual shunt.
次要结局
- Surgical technique success rate(Immediately after surgery)
- technique success rate(Immediately after surgery)
研究者
Pan Xiangbin
Principal Investigator
Chinese Academy of Medical Sciences, Fuwai Hospital