NCT00819793已完成不适用
Thoratec CentriMag VAS Failure-to-Wean From Cardiopulmonary Bypass Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 27
- 主要终点
- Survival
研究概览
简要总结
The purpose of the study is to evaluate the safety and effectiveness of the CentriMag ventricular assist system to help patients who have experienced heart failure during surgery and cannot be removed from cardiac bypass.
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
- •At least 18 years of age
- •Cardiac dysfunction due to failure-to-wean from cardiopulmonary bypass
- •Subjects who are on IABP, CPB, ECMO or CPS support prior to evaluation should have the device turned off, if possible, for the purpose of measuring inclusion hemodynamics. However, these devices should not be turned off in patients who would be harmed by interruption of support.
- •All subjects must meet the following criteria at the time of enrollment:
- •Hemodynamics:
- •cardiac index ≤ 2.2 L/min/m2
- •For patients being evaluated for left-sided support (LVAD): PCWP ≥ 18 mmHg or PADP ≥ 18 mmHg or LAP ≥ 18 mmHg
- •For patients being evaluated for right or biventricular support: CVP ≥ 15 mmHg or RAP ≥ 15 mmHg and RVSWI ≤ 4.1 gm/m2/beat
- •Enrollment without hemodynamic measurements due to frequent or unpredictable dysrhythmias, unacceptable cardiac function, or hemodynamic instability is allowed.
- •Placement of an intra-aortic balloon pump has been attempted unless contraindicated
- •All possible measures have been attempted to correct low arterial pH, arterial blood gas abnormalities, electrolytes, hypovolemia, hypervolemia, inadequate cardiac rate, dysrhythmias and residual hypothermia
- •Cardiac resuscitation using pharmacologic agents, and epicardial pacing (if appropriate and possible) has been attempted
- •Written, signed, and dated informed consent
排除标准
- •BUN > 100 mg/dl
- •Creatinine > 5 mg/dl
- •Presence of any investigational mechanical circulatory support device
- •Known history of liver cirrhosis or portal hypertension
- •Pulmonary infarction
- •Stroke, TIA or history of either condition within the last six months and/or any confirmed, existing neurologic deficits
- •Active systemic infection defined as positive blood cultures, core temperature >100.5 degrees, white blood count > 12,500, and treatment with antimicrobials
- •Participation in a clinical trial with any experimental treatment within 30 days prior to screening or previous participation in the present study
- •Other serious disease(s) limiting life expectancy
结局指标
主要结局
Survival
时间窗: 30 days post-support or to hospital discharge, whichever is longer OR to induction of anesthesia for implantation of a long-term device or heart transplant
Number of patients alive 30 days after device implantation
次要结局
- Improvement in Central Venous Pressure (CVP) and Mean Arterial Blood Pressure (MAP)(Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAP)
研究者
研究点 (27)
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