HVAD(TM) SMART 1.0 Study: A Prospective Study of the HVAD(TM) SysteM WAvefoRm and Logfile CharacTeristics
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Heart Failure Event Characterization
研究概览
简要总结
The purpose of HVAD Smart 1.0 study is to collect HVAD device data (i.e., waveform + logfile + pump parameter) in various clinical conditions (e.g., routine follow-up visits, experiencing adverse events) to support development of predictive and actionable algorithms. The collected data will be used to characterize HVAD flow waveform and logfile pattern changes that precede a qualifying adverse event, as well as characterize "normal" HVAD flow waveform and logfile patterns (subjects free from any qualifying adverse event, any hospital readmissions related to a SAE, or any parenteral medical therapy for heart failure management (e.g., inotropes, diuretics, etc.) or ultrafiltration in last 30 days). In addition, the study will collect data to evaluate the utility of CareLink in HVAD patients. The study will not involve any investigational testing and the market-released devices will used as per the approved labelling.
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
- •Greater than or equal to 18 years of age:
- •Refractory, advanced heart failure patient that is either: Prospectively identified as a candidate to receive the commercial HVAD system as their first durable left Ventricular Assist Device (LVAD) implant for approved indications; or within 10 days of receiving the commercial HVAD system as their first durable LVAD for approved indications
- •Patient provides written authorization and/or consent per institution and geographical requirements
排除标准
- •patient who is, or is expected to be inaccessible for follow up
- •patient with previous durable mechanical circulatory support device
- •patient with planned Bi-VAD procedure
- •patient with exclusion criteria required by local law
- •patient is currently enrolled in or plans to enroll in an concurrent drug and/or device study that may confound results (i.e., no required intervention that could affect interpretation of all-around product safety and/or effectiveness). Concomitant observational studies allowed if permitted by IRB/EC
结局指标
主要结局
Heart Failure Event Characterization
时间窗: data collected as events occur throughout study follow-up period; up to the 12 month follow-up visit
HVAD flow waveform and logfile pattern changes
次要结局
- CareLink Utilization(Up to 12 months post-implant)
- Qualifying Adverse Event Characterization(data collected as events occur throughout study follow-up period; up to the 12 month follow-up visit)
- Non-AE/SAE Characterization Group(data collected throughout study follow-up period; up to the 12 month follow-up visit)