Clinical Feasibility Study of the Magenta Elevate™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients With Cardiogenic Shock
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 8
- 主要终点
- Initial Safety
研究概览
简要总结
The Elevate™ CS Clinical Feasibility Study is designed to evaluate the initial safety, effectiveness, and device performance of the Magenta Elevate™ System in patients with cardiogenic shock due to isolated or predominant left ventricular failure.
详细描述
The Elevate™ CS Clinical Feasibility Study is planned as a prospective, single-arm, interventional study.
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
- 40 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiogenic shock of less than 24 hours duration.
- •Left ventricular ejection fraction < 45% and > 15%, as determined by echocardiography on the day of inclusion.
- •No more than mild right ventricular dysfunction, as determined by echocardiography on the day of inclusion.
- •Signed informed consent.
排除标准
- •Other causes of shock: hypovolemia, sepsis (any active systemic infection including acute myocarditis), pulmonary embolism or anaphylaxis.
- •Patient with oxygen saturation < 90% (pulse oximeter/arterial) at the planned time of device placement (uncorrected by oxygen supplementation or intubation).
- •Sustained VT (at the time of the enrollment).
- •Significant right heart failure/right ventricular dysfunction.
- •Awake patient who is unable to remain in a stable recumbent position due to restlessness or lack of cooperation for other reasons.
- •Hypertrophic obstructive cardiomyopathy.
- •Left ventricular thrombus.
- •Subjects with a placed IABP.
- •Mitral and/or aortic valve prothesis, or more than mild native mitral or aortic valve stenosis.
- •Aortic valve insufficiency ≥ 2+ (on a 4-grade scale).
- •Mechanical complication of myocardial infarction (e.g., ventricular septal rupture, papillary muscle rupture) or evidence of uncorrected Ventricular Septal Defect or Atrial Septal Defect (VSD/ASD).
- •Brain damage (e.g., anoxic) or suspected brain damage.
- •Stroke or transient ischemic attack within the past 3 months.
- •Uncorrectable abnormal coagulation parameters (defined as platelet count < 100,000 or INR > 2.0 or fibrinogen < 1.5 g/L) or active uncontrolled bleeding.
- •Allergy, sensitivity or intolerance to heparin, aspirin, Adenosine Diphosphate (ADP) receptor blockers, or contrast media, including known heparin-induced thrombocytopenia.
- •Known allergy, sensitivity or intolerance to nickel.
- •Known or suspected severe lung disease.
- •Evidence of any vascular disease that would preclude placement of the device (e.g., severely calcified and stenosed ilio-femoral vessels).
- •Aortic pathology, such as aortic aneurysms, extreme tortuosity, or calcifications that could pose an undue additional risk to the placement of a pLVAD device.
- •Any known or suspected disorder causing fragility of blood cells or hemolysis.
- •Subject participation in another investigational drug or device trial (post-market registries may be approved by Magenta Medical).
- •Life expectancy < 1 year due to comorbidities.
研究组 & 干预措施
Cardiogenic shock
Acute myocardial infarction or acutely decompensated heart failure and cardiogenic shock patients
干预措施: Elevate™ System (Device)
结局指标
主要结局
Initial Safety
时间窗: From device delivery through device removal
The rate of the composite of Major Device-Related Adverse Events
Device Effectiveness
时间窗: From baseline to 30 minutes of device activation
Hemodynamic stability and/or improvement from baseline following device activation, defined as: * Number (percentage) of patients with MAP\>60mmHg * Improvement in MAP
Device Performance
时间窗: From device delivery through device removal
* Rate of successful delivery of the Elevate™ System * Rate of successful deployment of the Elevate™ System * Rate of successful use of the Elevate™ System * Rate of successful retrieval of the Elevate™ System
次要结局
未报告次要终点