NCT00893828已完成不适用
Monitoring Pulmonary Artery Pressure by Implanted Device Responding to Ultrasonic Signal
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Continue detailed data collection of pressure readings from patients implanted with a RemonCHF device.
研究概览
简要总结
The PAPIRUS III study will continue to follow patients initially enrolled in PAPIRUS II. Pressure readings from the investigational device will continue to be collected and will be correlated to physiological changes during activities of daily living and protocol defined tests.
详细描述
This is a small clinical trial to determine the feasibility of a device & to test prototype device, where the primary outcome measure relates to feasibility and not to health outcomes.
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
- •Patient has been enrolled in the PAPIRUS II Study and has a RemonCHF pressure sensor implanted
- •Patient is willing and able to provide informed consent, participate in the Safety Follow-up Program and/or in the required tests associated with the clinical investigation (Core Study Program) at an approved clinical investigational center and at the intervals defined by the Clinical Investigational Plan.
排除标准
- •Patient enrolled in PAPIRUS II but not implanted with a RemonCHF Pressure Sensor
- •Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study (with the exception of the PAPIRUS II Study). Each instance would be brought to the sponsor to determine eligibility.
- •Age < 18 years
- •Women of childbearing potential who are, or might be, pregnant at the time of the study
结局指标
主要结局
Continue detailed data collection of pressure readings from patients implanted with a RemonCHF device.
时间窗: 24 months
次要结局
未报告次要终点
研究者
研究点 (1)
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