NCT03139721已完成不适用
Medtronic Hancock II® and Mosaic Mitral and Aortic Valves: A Study to Observe the Effects of the Stent Material Change to PEEK Post Approval Study (HAMMOCK PAS)
Medtronic Cardiac Surgery7 个研究点 分布在 3 个国家目标入组 122 人开始时间: 2017年6月19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
- 122
- 试验地点
- 7
- 主要终点
- Number of Deaths, Reinterventions, or Explants
研究概览
简要总结
This study is being conducted to satisfy the post-CE approval requirement.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subjects who require aortic or mitral valve replacement of their native valve.
- •Subject is geographically stable and willing to return to the implanting site for all follow-up visits.
- •Subject is of legal age to provide informed consent in the country where they enroll in the study.
- •Subject has been adequately informed of risks and requirements of the study and is willing and able to provide informed consent for participation in the clinical study.
排除标准
- •Subject requires concomitant replacement of the aortic and mitral valves.
- •Subject requires a replacement of a previously implanted prosthetic aortic or mitral valve.
- •Subject requires a Bentall procedure for replacement of aortic valve or aortic root.
结局指标
主要结局
Number of Deaths, Reinterventions, or Explants
时间窗: 3-years post implant
Number of deaths, reinterventions, or explants related to the valve
次要结局
- Peak Gradient(3-years post implant)
- Effective Orifice Area (EOA)(3-years post implant)
- Cardiac Index(3-years post implant)
- Performance Index(3-years post implant)
- Paravalvular Regurgitation(3-years post implant)
- Mean Gradient (mmHg)(1-year post implant)
- Effective Orifice Area Index (EOAi)(3-years post implant)
- Cardiac Output(3-years post implant)
- New York Heart Association (NYHA) Classification(3-years post implant)
- Peak Gradient (mmHg)(1-year post implant)
- Transvalvular Regurgitation(3-years post implant)
- Total Regurgitation(3-years post implant)
- Mean Gradient(3-years post implant)
研究者
研究点 (7)
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