NCT02755220已完成不适用
A Prospective, Mutli-center, Open Lable, Single Arm Study to Evaluate the Safety and Effectiveness of Cingularbio® Heart Valve in Aortic/Mitral Valve Replacement Patients
Shanghai Cingularbio Co. Ltd5 个研究点 分布在 3 个国家目标入组 197 人开始时间: 2016年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 5
- 主要终点
- device related adverse valve events
研究概览
简要总结
This study aimed to evaluate the safety and effectiveness of Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement in Chinese population
详细描述
single arm, 12 month follow up, mutile center, to assess the safety and effectiveness of Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria were as follows: 1) patient who had heart valve disease requiring a surgical replacement as indicated in the preoperative evaluation; 2) patient aged between 60-85 years; 3) patient whose preoperative heart function less than NYHA functional class IV; 4) patient who signed the informed consent before surgery; 5) patient who agrees to finish the follow-up. The
排除标准
- •were as follows: 1) patient with prior valve replacement; 2) patient who requires concomitant tricuspid or pulmonary valve replacement; 3) patient who requires concomitant coronary artery bypass graft surgery; 4) patient with active infective endocarditis or drug abuse; 5) patient whose life time expectancy less than 12 months; 6) patient who was unable to follow anticoagulation treatment.
结局指标
主要结局
device related adverse valve events
时间窗: 12 month
device related events including Thromboembolism, Valve thrombosis,Major hemorrhage, Major paravalvular leak
次要结局
- rate of procedural success(post-operative)
- the difference between baseline and 1 year in Effective orifice area (EOA)(1year)
- the difference between baseline and 1 year in pressure gradient (PG)(1year)
- the difference between baseline and 1 year in Peak aortic valve velocity(1year)
- improvement in NYHA functional class(1year)
- mortality(1 year)
- structural valve deterioration(1 year)
- reoperation(1 year)
- valve-related adverse events(1 year)
研究者
研究点 (5)
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