Acute Myocardial Infarction (AMI), Cardiogenic Shock, Heart Failure
Conditions
Brief 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.
Detailed description
The Elevate™ CS Clinical Feasibility Study is planned as a prospective, single-arm, interventional study.
Interventions
DEVICEElevate™ System
The Elevate™ percutaneous Left Ventricular Assist Device System
Sponsors
Magenta Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initial Safety | From device delivery through device removal | The rate of the composite of Major Device-Related Adverse Events |
| Device Effectiveness | 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 | 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 |
Countries
Georgia, Israel
Contacts
CONTACTYelena Lalazar Sr. Director Clinical Affairs
STUDY_DIRECTORYelena Lalazar
Magenta Medical
Outcome results
None listed