Advanced Impella® SmartAssist® System for Patient Monitoring & Treatment: The Smart Pump Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Abiomed Inc.
- 入组人数
- 35
- 试验地点
- 11
- 主要终点
- The ability to calculate and display cardiac output (CO).
研究概览
简要总结
To demonstrate that the Impella® Hemodynamic Platform (the "Study Device") is safe, and measurements obtained are as good as currently used methods. These measurements include how much pressure the heart is generating and how much blood your heart is pumping during the PCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥ 18 years
- •Subject presents for elective PCI
- •Subject or the subject's LAR has signed the informed consent
- •Subject indicated for Impella® support
排除标准
- •Any contraindication or inability to place an Impella® including tortuous vascular anatomy, femoral bruits or absent pedal pulses
- •Cardiogenic shock defined as systemic hypotension (SBP<90mmHg or the need for inotropes/vasopressors to maintain an SBP >90mmHg) plus one of the following:
- •Any requirement for inotropes/vasopressors prior to arrival at the catherization lab
- •Clinical evidence of end organ hypoperfusion
- •Use of IABP or any other circulatory support device
- •Suspected systemic active infection
- •Suspected or known pregnancy
- •Known contraindication to heparin, pork, pork products, or contrast media
- •Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures
- •Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device which has not reached its primary end point.
- •Subject belongs to a vulnerable population [Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention
结局指标
主要结局
The ability to calculate and display cardiac output (CO).
时间窗: Through study completion, approximately 2 days
Defined as the number of times a CO calibration sequence is successfully completed and the CO is displayed divided by the number of times the pinging sequence is attempted. The endpoint is a rate and therefore has no units of measure. It is the "number of times CO was successfully completed, and CO is displayed" divided by the "number of times the pinging sequence was attempted"
次要结局
未报告次要终点