Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock

Summary

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.

Eligibility

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.

Conditions4

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