CardioMEMS™ HF System Real-World Evidence Post-Approval Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Two-Year Survival in the Primary Cohort (NYHA Class II subjects)
研究概览
简要总结
The purpose of this post-approval study (PAS) is to evaluate the long-term safety and effectiveness of the CardioMEMS™ HF System using real-world evidence (RWE) methods.
详细描述
Subjects will be identified in Abbott's Merlin.net remote monitoring database. Merlin.net data will be linked to Medicare fee-for-service (FFS) claims data to longitudinally track outcomes. Each subject will be followed for a minimum of 36 months.
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 PA Sensor and enrolled in Merlin.net
- •Subject resides in the United States as documented in Merlin.net
- •NYHA Class II or Class III as documented in Merlin.net at the time of CardioMEMS implant (only NYHA Class II subjects contribute to the Primary Cohort)
- •Subject identified in Merlin.net data can be linked to Medicare FFS claims
- •Subject is enrolled in Medicare Part A and B, and not enrolled in Medicare Part C, at implant and for 12 months prior to implant, to establish qualification for CardioMEMS
- •Subject ≥18 years of age at time of CardioMEMS implant
排除标准
- •Subject received heart transplant or durable mechanical circulatory support device implant (i.e., left/right/bi-ventricular assist device) prior to CardioMEMS implant
结局指标
主要结局
Two-Year Survival in the Primary Cohort (NYHA Class II subjects)
时间窗: 2 years
Evaluate survival for the Primary Cohort compared to a pre-specified performance goal of 71.7% survival at 2 years.
Two-Year Survival in NYHA Class II subjects without a history of severe renal disease
时间窗: 2 years
Compare survival in a subset of subjects from the Primary Cohort without a history of severe renal disease to a pre-specified performance goal of 71.7% survival at 2 years
次要结局
- Two-Year Survival in the Full Cohort (NYHA Class II and Class III subjects)(2 years)
- Two-Year Survival in NYHA Class II and III subjects without a history of severe renal disease(2 years)