THEME Registry: TandemHeart Experiences and MEthods (THEME Registry)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 365
- 试验地点
- 16
- 主要终点
- Survival to Pump removal with myocardial and/or pulmonary recovery, durable ventricular assist device (VAD) implant or transition to another mechanical support device, or cardiac and/or lung transplant
研究概览
简要总结
This study is intended to be a multicenter, prospective observation registry. By collecting prospective descriptive data, provide insight into disease defining characteristics resulting in the clinical decision to use TandemHeart® or LifeSPARC™ System for mechanical support and enhance knowledge of best practice regarding clinical management, weaning and removal/exit strategies.
详细描述
The TandemHeart or LifeSPARC percutaneous extracorporeal life support system is used to support circulation. The percutaneous cannulas facilitate access to the venous and arterial circulatory vessels. When connected to the TandemHeart or LifeSPARC centrifugal pump, mechanical support is provided with sufficient cardiac power to perfuse the organs of the body.
It is anticipated that THEME Registry™ analysis will provide insight into disease defining characteristics resulting in the clinical decision to use the TandemHeart or LifeSPARC System for mechanical support and enhance knowledge of best practice regarding clinical management, weaning and removal. The progression of the illness prior to, during and following support will be collected. The THEME Registry will collect descriptive data regarding patient selection criteria and the clinical management of the patient including strategies used to wean and remove the device. Specifically the objectives of the THEME Registry are:
- Summarize the characteristics of the patients who receive the System for temporary percutaneous mechanical support with or without an oxygenator, including demographics, pre-implant medical history, details of present illness, exit strategy.
- Evaluate the timing of initiation of System support in relation to the progression of the presenting illness and the association of this with clinical outcomes.
- Collect descriptive data related to clinical management of the patient while on mechanical support, including procedural details, duration of support, anticoagulation, hemodynamics and biochemical parameters to define trends in clinical care and the association of this decision-making with clinical outcomes.
- Collect hospital discharge information including Intensive Care Unit (ICU) and Hospital length of stay (LOS).
- Collect survival and exit strategy status at 30 and 180 days post-initial System insertion.
- Collect serious adverse events from the time of Pump insertion through removal of the System (or Pump).
- Provide data regarding patient characteristics and outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patient has had the TandemHeart or LifeSPARC System inserted percutaneously (e.g. in the cath lab or peri-operatively)
- •Patient (or legally authorized representative [LAR]) has signed informed consent
排除标准
- •Patient is incarcerated (prisoner)
- •Participation in a clinical trial of an investigational drug or device
结局指标
主要结局
Survival to Pump removal with myocardial and/or pulmonary recovery, durable ventricular assist device (VAD) implant or transition to another mechanical support device, or cardiac and/or lung transplant
时间窗: 180 Days
Survival
次要结局
- Occurrence of Serious Adverse Events (SAEs) related to the device while on support(Approximately 72 hours after start of support)