NCT02279979终止不适用
Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 12
- 主要终点
- Clinical stabilization defined as improvement of Cardiac Index to > 2.2 L/min/m2
研究概览
简要总结
The primary objective of this study is to assess reasonable safety and performance of the HeartMate PHP to provide hemodynamic support for up to 72 hours in patients with cardiogenic shock requiring stabilization.
详细描述
The HeartMate PHP is a catheter-based axial flow pump designed to provide partial left ventricular circulatory support. This prospective, nonrandomized, controlled, single-arm, multi-center, open-label trial will evaluate the safety and performance of the device in patients with cardiogenic shock.
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
- — 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is indicated for left ventricular support according to current medical guidelines ("current medical guidelines" applies only to patients enrolled in Germany)
- •Patient has a cardiac index of < 2.2 L/min/m2 and is being treated with at least one moderate dose inotrope or at least one moderate dose of vasopressor (e.g., milrinone ≥0.3 mcg/kg/min, dopamine > 5 mcg/kg/min, dobutamine > 5 mcg/kg/min) AND:
- •PCWP > 18 mmHg, AND
- •Systolic blood pressure < 100 mmHg, AND
- •Decreased organ perfusion as evidenced by urine output of 50 mL/hr OR increased creatinine of 0.3 mg/dl from baseline obtained within 2 weeks, OR cool extremities
- •Written, signed, and dated informed consent
排除标准
- •Patient is >85 years of age
- •Right ventricular failure requiring mechanical circulatory support
- •ST elevation myocardial infarction (STEMI) within 30 days of procedure
- •Cardiac arrest within 7 days of procedure requiring CPR
- •Current treatment with mechanical circulatory device such as IABP, ECMO, centrifugal pump, etc.
- •Documented acute myocarditis
- •Active major cardiac rhythm disturbances (e.g., ventricular tachycardia, ventricular fibrillation).
- •Hypertrophic disease or any left ventricular outflow tract obstruction
- •Active sepsis defined as bacteremia, fever ≥ 101.5 degrees F
- •Mural thrombus in the left ventricle
- •History of aortic valve replacement
- •End-stage renal disease requiring dialysis
- •Documented presence of aortic stenosis (orifice area of 1.5 cm2 or less)
- •Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher)
- •Platelet count < 100,000
- •Allergy or Intolerance to heparin, aspirin, clopidogrel, ionic and nonionic contrast media, or any other potentially required anticoagulants or antiplatelet therapy drugs
- •Known coagulopathies
- •Presence of risk factors for severe liver and/or renal dysfunction
- •Stroke within 90 days of enrollment
- •Significant peripheral vascular disease
- •History of heparin induced thrombocytopenia
- •Patient is pregnant or planning to become pregnant during the study period
- •Patient is breastfeeding.
- •Any active disease (e.g., active cancer) which could affect the patient's participation in the study, or if life expectancy is less than 1 year.
- •Any active disease in which the investigator determines would make the patient an inappropriate candidate for the study.
- •Participation in another clinical study of an investigational drug or device that has not met its primary endpoint
结局指标
主要结局
Clinical stabilization defined as improvement of Cardiac Index to > 2.2 L/min/m2
时间窗: 72 hours
次要结局
- An assessment of major adverse events(72 hours)
研究者
研究点 (12)
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