Investigation to Optimize Hemodynamic Management of HeartMate II™ Left Ventricular Assist Device Patients Using the CardioMEMS™ Pulmonary Artery Pressure Sensor in Advanced Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 23
- 主要终点
- Six Minute Hall Walk (6MHW) Distance
研究概览
简要总结
This observational post market study is intended to characterize hemodynamic-guided management of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional status, quality of life, and readmissions
详细描述
The study is an observational, single group study where all participants receive the same intervention. The study plans to enroll up to 100 patients at 25 US sites. All patients will have a HeartMate Left Ventricular Assist Device (LVAD) and a CardioMEMS device implanted as standard of care. After enrollment into the study, the patient will be followed until six month follow up completion. The objective of this clinical investigation is to understand the role of hemodynamic monitoring in LVAD patients and:
- Characterize PA pressure measurements with the CardioMEMS HF System in LVAD patients under different clinical and physiologic conditions
- Characterize the effects of PA pressure on functional status, quality of life, and hospital readmissions of LVAD patients
- Evaluate target ranges for PA pressure and assess the impact of medication and pump speed changes on PA pressures
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 has CardioMEMS HF PA Sensor and a commercially-approved HeartMate LVAD (Group A) OR Subject has commercially-approved HeartMate LVAD, is experiencing NYHA class III symptoms, and has had a previous HF hospitalization and meets FDA indications for CardioMEMS. The CardioMEMS PA Sensor must be implanted within 72 hours of consent (Group B)
- •Signed an informed consent form and agreed to provide access to patient and device data (including CardioMEMS Merlin.net data)
- •No connectivity or transmission problems with CardioMEMS
- •On HeartMate LVAD support for at least 3 months
- •Age ≥ 18 years
排除标准
- •Current participation in an investigation that is likely to confound study results or affect study outcome
- •Current participation in the MOMENTUM3 IDE Clinical trial and has not completed the two year follow-up for that trial
- •Inability to perform 6MHW test due to conditions other than heart failure (e.g. severe arthritis, orthopedic issues, amputation etc.)
结局指标
主要结局
Six Minute Hall Walk (6MHW) Distance
时间窗: Six Months
Change in 6MHW distance compared to baseline. The six-minute hall walk (6MHW) test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
次要结局
未报告次要终点