CardioMEMS European Monitoring Study for Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 2
- 主要终点
- Freedom From Device/System Related Complications
研究概览
简要总结
The purpose of this study is to characterize the use of the CardioMEMS™ HF System when used in a real-world setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Indicated to receive a CardioMEMS sensor implant per the CardioMEMS™ HF System User's Manual
- •≥ 18 years of age
- •Diagnosis of New York Heart Association (NYHA) Class III Heart Failure at the time of sensor implantation
- •Hospitalization for worsening HF, as defined in the protocol, within 12 months prior to the CardioMEMS HF System implant
- •Subjects with reduced Left Ventricular Ejection Fraction (LVEF) must be on stable Guideline Directed Medical Therapy (GDMT) as tolerated
- •Written informed consent obtained from subject
排除标准
- •Known coagulation disorders or inability to take two types of blood thinning medications for one month after the sensor is implanted
- •Subjects deemed a candidate for transplant, Ventricular Assist Device, or hospice care in the next 12 months or are otherwise not expected to be able to complete the study follow up
研究组 & 干预措施
CardioMEMS HF System
Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications.
干预措施: CardioMEMS HF System (Device)
结局指标
主要结局
Freedom From Device/System Related Complications
时间窗: one year
This primary safety endpoints is freedom from device/system related complications (DSRCs) which is defined as an adverse event that is, or is possibly, related to the device/system (wireless pressure sensor or external electronics) and has at least one of the following characteristics: is treated with invasive means (other than intramuscular medication or right heart cauterization which is used for diagnostic purposes); results in death of the subject; or results in the explant of the device. The pre-specified goal of this endpoint was was to have a freedom from DSRC greater than 0.80 at 12 months post-implant.
Percent of Successful Pulmonary Artery Pressure Data Transmissions
时间窗: one year
Patient data transmission success is defined as the percentage of successful transmissions among attempted transmissions. All subjects who were consented and implanted with a pressure sensor regardless of study completion status are included in this analysis. All attempted data transmissions through the 12-month visit or death or withdrawal are included in the analysis. For each subject, the patient data transmission success rate (% of successful transmission) was calculated as total number of successful transmissions divided by total attempted transmissions within 12 months.
Freedom From Pressure Sensor Failure
时间窗: one year
This primary safety endpoints is freedom from pressure sensor failure greater than 0.90 at 12 months post-implant.
次要结局
- Heart Failure Hospitalization (HFH) Rate(one year)