Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects With Mitral Annular Calcification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 8
- 主要终点
- Number of Participants With Composite Endpoint of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs), as Classified by the Clinical Events Committee (CEC)
研究概览
简要总结
This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular calcification (MAC). Subjects satisfying the study inclusion/exclusion criteria will undergo a procedure to implant the Tendyne mitral valve replacement device.
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
Number of Participants With Composite Endpoint of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs), as Classified by the Clinical Events Committee (CEC)
时间窗: 30 days post implant
Definition of Device Success: All of the following must be present: 1. Absence of procedural mortality or stroke; and 2. Proper placement and positioning of the device, and 3. Freedom from unplanned surgical or interventional procedures related to the device or access procedure; and 4. Continued intended safety and performance of the device, including: i. No evidence of structural or functional failure ii. No specific device-related technical failure issues or complications iii. Reduction of MR to either optimal or acceptable levels without significant structural valve dysfunction and with no greater than mild (1+) paravalvular MR (and without associated hemolysis). All device- or procedure-related adverse events will be adjudicated by an independent clinical events committee
次要结局
未报告次要终点