CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CardioMEMS
- 入组人数
- 550
- 试验地点
- 2
- 主要终点
- Freedom From Pressure Sensor Failure
研究概览
简要总结
This is a prospective, multi-center, randomized, single-blind clinical trial conducted in the United States (US). The objective of the study is to evaluate the safety and efficacy of the HF Pressure Measurement System in reducing heart failure (HF) related hospitalizations in a subset of subjects suffering from HF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 HF ≥ 3 months, with either preserved or reduced LVEF
- •Diagnosis of NYHA Class III HF (historical assessment documented at screening visit)
- •Subjects with reduced LVEF must be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the subject is intolerant to beta blockers, ACE-I or ARB. Beta blockers and ACE-I (or ARB) doses should be stable for one month prior to study entry.
- •At least 1 HF hospitalization within 12 months of Screening Visit
- •Subjects with pulmonary artery branch diameter sized between 7mm and 15mm (implanted vessel)
排除标准
- •Subjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosis
- •Subjects, in the Investigator's opinion, unable to tolerate a right heart catheterization
- •Subjects who have had a major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of Screening Visit
- •Subjects with Cardiac Resynchronization Device (CRT) implanted ≤ 3 months prior to enrollment
- •Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal dialysis
- •Subjects likely to undergo heart transplantation within 6 months of Screening Visit
- •Subjects with congenital heart disease or mechanical right heart valve(s)
- •Subjects with known coagulation disorders
- •Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel
结局指标
主要结局
Freedom From Pressure Sensor Failure
时间窗: 6 months
A pressure sensor failure occurs when the sensor malfunctions to the point that no readings can be obtained from it after all attempts are exhausted including troubleshooting the system to rule out any problems with the electronic components.
Rate of Heart Failure Related (HFR) Hospitalizations
时间窗: 6 months
Freedom From a Device/System-related Complication (DSRC).
时间窗: 6 months
A DSRC is an adverse event that is, or is possibly, related to the HF Pressure Measurement System and at least one the following: * is treated with invasive means (other than intramuscular medication or a right heart catheterization with a Swan-Ganz measurement which is used for diagnostic purposes) * results in the death of the subject * results in the explant of the device
次要结局
- Proportion of Patients Hospitalized for Heart Failure(6 months)
- Change From Baseline in Pulmonary Artery Mean Pressure(6 months)
- Days Alive Outside of the Hospital(6 months)
- Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ)(6 months)