NCT06779552招募中不适用
CardioMEMS HF System Coverage with Evidence Development Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- HF Hospitalization Rate.
研究概览
简要总结
The purpose of the CardioMEMS CED Study is to determine if pulmonary artery (PA) pressure-guided heart failure management using the CardioMEMS™ HF System improves long-term health outcomes in heart failure (HF) patients in the real-world setting.
详细描述
The CardioMEMS CED Study will assess 2-year HF hospitalization rates and survival for all-cause mortality in heart failure subjects managed with the CardioMEMS HF system, as compared to a contemporaneous control of HF subjects managed without PA pressure-guidance.
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 implanted with a CardioMEMS pressure sensor (treatment arm only)
- •Subject >=18 years of age at time of implant
- •Subject has a history of acute decompensated HF or HF-related congestion defined by at least one of the following qualifying event types: HF hospitalization, elevated BNP/NT-proBNP
排除标准
- •Subject has history of heart transplant or durable mechanical circulatory device
- •Subject hospitalized with cardiogenic shock or sepsis
- •Subject received prior PA pressure sensor implant (control arm only)
结局指标
主要结局
HF Hospitalization Rate.
时间窗: 2 years
Compare HF hospitalization rate between the treatment and control groups.
次要结局
- Two-Year Survival(2 years)
研究者
研究点 (1)
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