Clinical Investigation of the Perceval S Sutureless Heart Valve
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 355
- 试验地点
- 39
- 主要终点
- Primary Efficacy Endpoint
研究概览
简要总结
To demonstrate the safety and effectiveness of the Perceval S heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
详细描述
This investigation is a prospective, non-randomized, multi-center trial of the PERCEVAL valve implanted in patients requiring aortic valve replacement. The study will be conducted in a maximum of 25 centers in the United States. Patients will be evaluated at each of the following time intervals:preoperative, at implant, in the early postoperative period, in the late postoperative period (between 3 and 6 months postoperatively), at 1 year (between 11 and 13 months postoperatively), and annually until study completion. The duration of the study is anticipated to be 5 years.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Primary Efficacy Endpoint
时间窗: One-year
To demonstrate that the rate of valve success for the PERCEVAL S valve is comparable to that of appropriate historical controls
Primary Safety Endpoint
时间窗: One-year
To demonstrate that the complication and survival rates for the PERCEVAL S valve are comparable to appropriate historical controls manifested as objective performance criteria (OPCs) and to that reported for other stented bioprostheses in the literature
次要结局
- Secondary Efficacy Outcomes(One-year)