Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Minnesota
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Minneapolis、Minnesota、美国、55407
- Abbott Northwestern Hospital Cardiac Surgical Associates
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Rochester、Minnesota、美国、55905
- Mayo Clinic
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North Carolina
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Asheville、North Carolina、美国、28801
- Mission Hospital
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Hospital of the University of Pennsylvania
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Tennessee
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Nashville、Tennessee、美国、37232
- Vanderbilt Heart Institute
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Utah
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Murray、Utah、美国、84157
- Intermountain Heart & Lung Surgical Associates
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Subjects implanted with a Trifecta valve at one of the US sites of the IDE study.
- Subject met eligibility criteria of IDE study
- Subject agrees to complete study follow-up visits
- Subject provides written informed consent
Exclusion Criteria:
- Subject currently participating in another device or drug study
- Subject unable or unwilling to return for study follow-up visits
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Trifecta Valve Group
Subjects implanted with a Trifecta valve.
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surgical replacement of aortic valve
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Late Adverse Event Incidence
大体时间:5 years
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Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100] |
5 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Characterize Patient NYHA Functional Classification Status
大体时间:5 years
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The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256. |
5 years
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Report the Hemodynamic Performance of the Valve
大体时间:5 years
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Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg. Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve. Mean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size. |
5 years
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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Trifecta valve的临床试验
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JC Medical, Inc.Bright Research Partners; Cardiovascular Research Foundation, New York; Minneapolis Heart Institute...尚未招聘主动脉瓣反流 | 主动脉瓣疾病混合
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Abbott Medical Devices完全的
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Chinese Academy of Medical Sciences, Fuwai Hospital尚未招聘