NCT02858245终止不适用
A Feasibility Registry on Use of Actigraphy Monitoring in Degenerative Mitral Regurgitation (DMR) Subjects Receiving the MitraClip® Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- Observational change in daily reported activity levels (counts/min) as assessed by actigraphy, from baseline to 30 days post MitraClip implantation
研究概览
简要总结
A prospective, open-label, and multi-centered feasibility registry.
详细描述
This is a prospective, open-label, and multi-centered feasibility registry (single arm study). Approximately 36 subjects with prohibitive risk degenerative mitral regurgitation (DMR) who receive at least 1 commercial MitraClip will be registered at up to 10 US sites.
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
- •Subject must consent to receiving the MitraClip device
- •Subject must consent, be able, and commit to wearing the Actiwatch continuously for approximately 7 months
- •Subject must consent to use of their data from this registry for purposes of exploratory research and publication and presentation
排除标准
- •Subject is not a member of vulnerable population
- •Subject must not have any disabilities that preclude reliable data collection from the Actiwatch, e.g., epilepsy with uncontrolled recurring episodes, serious stage degenerative/disabling disease (e.g. Parkinson's disease), inability to walk or will require walking aids, etc.
结局指标
主要结局
Observational change in daily reported activity levels (counts/min) as assessed by actigraphy, from baseline to 30 days post MitraClip implantation
时间窗: At 30 days
Phillips Actiwatch Spectrum PRO is the device being used to capture the primary outcome measure
次要结局
- Levels of daily and weekly activity as assessed by actigraphy(At 5 months)
- Patterns of daily Sleep/Wake by actigraphy(At 6 months)
- NYHA Functional Class(At 30 days)
- Mitral Regurgitation severity(At 30 days)
- Echocardiographic assessment(At 30 days)
- Distance walked 6 minute walk test (6MWT)(At 30 days)
- Health-related quality of life (QoL)(At 30 days)
研究者
研究点 (8)
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