Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock

Ki vehet részt

• 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

Ki nem vehet részt

• Subject participation in another investigational drug or device trial (post-market registries may be approved by Magenta Medical)
• Other causes of shock: hypovolemia, sepsis (any active systemic infection including acute myocarditis), pulmonary embolism or anaphylaxis
• Significant right heart failure/right ventricular dysfunction
• 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)
• Stroke or transient ischemic attack within the past 3 months
• 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)
• Any known or suspected disorder causing fragility of blood cells or hemolysis
• Uncorrectable abnormal coagulation parameters (defined as platelet count < 100,000 or INR > 2.0 or fibrinogen < 1.5 g/L) or active uncontrolled bleeding
• 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)
• 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
• Brain damage (e.g., anoxic) or suspected brain damage
• Aortic pathology, such as aortic aneurysms, extreme tortuosity, or calcifications that could pose an undue additional risk to the placement of a pLVAD device
• Life expectancy < 1 year due to comorbidities