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
- 4
- 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
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)