CSI Percutaneous Ventricular Assist Device (pVAD) First in Human Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Procedural success
研究概览
简要总结
This study will collect initial clinical data on the CSI pVAD system to inform device design and finalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 是
入选标准
- •Male or non- pregnant female ≥ 18 years of age
- •Life expectancy ≥ 1 year
- •Ejection Fraction (EF) >15% and ≤ 40%
- •Scheduled for an elective high risk percutaneous coronary intervention
排除标准
- •Hemodynamically unstable MI with elevated cardiac biomarker and no evidence of at least 1 consecutive CK-MB or troponin value trending downward from a previous value OR ST-Elevation Myocardial Infarction (STEMI) within 14 days of Index Procedure
- •Pre-Procedure cardiac arrest within 24 hours of enrollment requiring cardiopulmonary resuscitation
- •Cardiogenic shock
- •Left ventricular (LV) mural thrombus
- •Presence of a prosthetic valve or a heart constrictive device
- •Aortic stenosis
- •Moderate or severe aortic regurgitation (≥ 2+ by echo)
- •Severe peripheral vascular disease that will preclude the use of a 12F access sheath, which is required for the insertion of the CSI pVAD catheter
- •Severe aortic tortuosity
- •Severe aortic calcification
- •Vasculature will not tolerate a right heart catheterization
- •Renal dysfunction (serum creatinine ≥ 2.5 mg/dl) or requirement for hemodialysis
- •Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3X upper lab normal (ULN) or Internationalized Normalized Ratio (INR) ≥ 2 or lactate dehydrogenase (LDH) > 2.5X ULN
- •Uncorrectable abnormal coagulation parameters
- •History of heparin induced thrombocytopenia
- •Sustained ventricular tachycardia
- •Stroke or transient ischemic attack (TIA) within 6 months or any permanent neurological deficit
- •Chronic anemia (hemoglobin < 8 g/dL)
- •Subject may require long term support with a commercially available hemodynamic support device
- •Active systemic infection requiring oral or intravenous antibiotics
- •Allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or antiplatelet therapy drugs that cannot be adequately premedicated
- •Allergy or intolerance to system components
- •Participation in another investigational drug or device study
结局指标
主要结局
Procedural success
时间窗: Intraprocedural
Delivery of the device to the correct anatomical position, successful operation and removal of the CSI pVAD system
Intraprocedural Major Device-Related Adverse Events
时间窗: 24-hours Post-Index Procedure
Composite incidence of: * Cardiovascular death * Clinically significant myocardial infarction (MI) defined as the composite of MI events per Society for Cardiovascular Angiography and Intervention (SCAI) periprocedural MI and Fourth Universal MI definitions * Any repeat revascularization (PCI or CABG) * Stroke defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.
次要结局
未报告次要终点