NCT04073420招募中不适用
Medtronic Cardiac Surgery Post Market Clinical Follow-up Registry
Medtronic Cardiac Surgery51 个研究点 分布在 10 个国家目标入组 2,700 人开始时间: 2019年12月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,700
- 试验地点
- 51
- 主要终点
- Identify unique failure modes
研究概览
简要总结
This registry is being conducted to support ongoing post-market surveillance activities.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- •Patient has or is intended to receive or be treated with an eligible product
- •Patient is within enrollment window of treatment/therapy received at the time of their initial Registry enrollment, or meets criteria for retrospective enrollment
排除标准
- •Patient who is, or is expected to be, inaccessible for follow-up
- •Patient prohibited from participation by local law
- •Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and/or device study that may confound results
研究组 & 干预措施
Surgical Valve Replacement and/or Repair Patients
干预措施: Surgical Heart Valve Repair Products (Device)
Surgical Valve Replacement and/or Repair Patients
干预措施: Surgical Heart Valve Replacement Products (Device)
结局指标
主要结局
Identify unique failure modes
时间窗: 10 years
Identify trends in adverse device effects
时间窗: 10 years
次要结局
未报告次要终点
研究者
研究点 (51)
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