Testing a heart pump device for cardiogenic shock
Tests the Elevate heart pump in adults with cardiogenic shock from left ventricular failure.
Plain-language title generated from the registry record
Registry title: Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock
Key facts
- Where
- Tbilisi, GeorgiaSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 89 years old?
Source: NCT07293923, who can take part
Where in Georgia
- Israeli Georgian Medical Research Clinic HelsicoreTbilisi, GeorgiaTaking people
- Tbilisi Heart CenterTbilisi, GeorgiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Magenta Medical Ltd.
- Trial code
- NCT07293923
- Record updated
- 16 July 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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.