Remon CHF Medical Device Clinical Investigation PAPIRUS II: Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Serious adverse events related to implantation or the device
研究概览
简要总结
The purpose of this study is to evaluate and document appropriate clinical safety and performance of the Remon CHF Implantable Pressure Sensor including the corresponding delivery system, the Remon CHF Home Unit, the Remon CHF Clinic System devices and associated application software. It is a small clinical trial to determine the feasibility of the device. The primary outcome measure relates to feasibility and not to health outcomes.
详细描述
This study was a prospective feasibility, non-randomised, singlearm, multi-centre, interventional clinical investigation performed at 4 international sites. Patients were implanted with the Remon CHF Implantable Pressure Sensor utilizing the corresponding delivering system. Measurements were taken with the Remon CHF Home Unit and the Remon CHF Clinic System. Follow-up visits took place at one, three and six months after implant.
Per protocol, a minimum of 30 patients was required to demonstrate safety of the device.
The study was conducted in accordance with ISO 14155:2003 (parts I and II), the Declaration of Helsinki and all applicable local and national regulations in the countries of submission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
盲法说明
No masking
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who exhibit signs and symptoms of NYHA Class III or IV heart failure.
- •Patients who are able to visit the clinic frequently during the 6 months following implantation.
- •Patients who are willing and able to perform all follow-up procedures.
排除标准
- •Patients under the age of 18
- •Pregnant women or women that plan to get pregnant during the study.
- •Patients with, tricuspid or pulmonic stenosis, pulmonary stents, right sided mechanical heart valves
- •Contraindication to antiplatelet therapy (aspirin and clopidogrel)
- •Patients suffering from active infection (on antibiotic therapy)
- •Known intracardiac mass (right atrial or right ventricular)
- •Patients who have been implanted with a VAD
- •Patients who are candidates for listing for heart transplantation if it is deemed that they have a possibility of receiving a heart within the next 6 months
- •Patients that have lead implanted at the heart right side of the heart within the last 6 months
- •Patients with any terminal illness, or with a life expectancy of less than 6 months
- •Patients that are unable to lie flat for the duration of the procedure
- •Patients that are unable to operate the home unit (due to physical or mental constrain)
- •Patients after pneumonectomy
- •Patients treated with oral anticoagulants INR > 1.5 prior to catheterization
- •Patients with severe chronic renal failure (creatinine > 2.5 mg/dl)
- •Patients suffered from acute myocardial infarction within the three months prior the study
- •Patients that underwent open heart surgery within 4 weeks prior the study.
结局指标
主要结局
Serious adverse events related to implantation or the device
时间窗: 6
Primary Device Safety Objective: Serious Adverse Device Effects rate during 6 months following implantation (device or delivery system related) and Implantation related Serious Adverse Events rate during 6 months following implantation
次要结局
- Device accuracy(6 months)