Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock

Clinical Feasibility Study of the Magenta Elevate™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients With Cardiogenic Shock

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.

The Elevate™ CS Clinical Feasibility Study is planned as a prospective, single-arm, interventional study.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.