CardioMEMS HF System Post Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,214
- 试验地点
- 1
- 主要终点
- Heart Failure Hospitalization (HFH) Rate
研究概览
简要总结
The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting.
详细描述
The primary objective of this study is to demonstrate the safety and to report clinical performance of the CardioMEMS™ HF System in real world setting.
Prospective, non-randomized, open-label, multi-center, post-market study designed to characterize the use of the CardioMEMS™ HF System in a real-world setting in the US; N=1200. It is the condition of approval study.
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
- •Diagnosis of NYHA class III heart failure
- •At least 1 heart failure hospitalization within previous 12 months
- •Patients with reduced LVEF heart failure should be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the patient is intolerant to beta blockers, ACE-I or ARB
- •Patients with BMI >35 will require their chest circumference to be measured at the axillary level. If > 65 inches the patient will not be eligible for the study.
- •Pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the right heart catheterization)
排除标准
- •Active infection
- •History of recurrent (> 1) pulmonary embolism or deep vein thrombosis
- •Inability to tolerate a right heart catheterization
- •A major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within previous 2 months
- •Cardiac resynchronization device (CRT) implanted within previous 3 months
- •Glomerular Filtration Rate (GFR) < 25 ml/min (obtained within 2 weeks of implant) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
- •Congenital heart disease or mechanical right heart valve
- •Likely to undergo heart transplantation or VAD within the next 6 months
- •Known coagulation disorders
- •Hypersensitivity or allergy to aspirin, and/or clopidogrel
结局指标
主要结局
Heart Failure Hospitalization (HFH) Rate
时间窗: one year
Annualized HFH rate parameter at 1 year versus the HFH rate in the year prior to enrollment using an Andersen-Gill method for recurrent events and robust sandwich variances to account for within-subject correlation. If the two-sided, upper 95% confidence interval for the hazard ratio (HR) is less than 1.0, then the primary effectiveness endpoint was met.
Freedom From Pressure Sensor Failure
时间窗: two year
A Sensor failure occurs when no readings can be obtained from it after troubleshooting the system to rule out any problems with the external electronics. The primary safety analyses were based on the following objective performance criteria: a) the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80% and b) the lower limit of the two-sided 95% confidence interval on the freedom from pressure sensor failure rate at 24 months is greater than 90%. These primary safety endpoints were tested hierarchically, testing for freedom from DSRCs first, in order to control for multiplicity.
Freedom From Device and/or System Related Complication (DSRC)
时间窗: two years
As defined in the study protocol, a DSRC is 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 catheterization which is used for diagnostic purposes); results in death of the subject; results in the explant of the device. The primary safety analyses were based on the following objective performance criteria: a) the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80% and b) the lower limit of the two-sided 95% confidence interval on the freedom from pressure sensor failure rate at 24 months is greater than 90%. These primary safety endpoints were tested hierarchically, testing for freedom from DSRCs first, in order to control for multiplicity.
次要结局
未报告次要终点