Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock

Magenta Medical

Status

Enrolling

Conditions

Acute Myocardial Infarction (AMI)

Heart Failure

Cardiogenic Shock

Treatments

Device: Elevate™ System

Study type

Interventional

Funder types

Industry

Identifiers

NCT07293923

DRD00691

Details and patient eligibility

About

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.

Full description

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

Enrollment

10 estimated patients

Sex

All

Ages

40 to 89 years old

Volunteers

No Healthy Volunteers

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.