Actively Recruiting
Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock
Led by Magenta Medical Ltd. · Updated on 2026-02-27
10
Participants Needed
5
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cardiogenic shock lasting less than 24 hours
- Left ventricular ejection fraction less than 45% and more than 15%, confirmed by echocardiography on the day of inclusion
- No more than mild right ventricular dysfunction, confirmed by echocardiography on the day of inclusion
- Signed informed consent
You will not qualify if you...
- Other causes of shock such as hypovolemia, sepsis, pulmonary embolism, or anaphylaxis
- Oxygen saturation below 90% at planned device placement time, not corrected by oxygen or intubation
- Sustained ventricular tachycardia at enrollment
- Significant right heart failure or right ventricular dysfunction
- Awake patient unable to stay in stable lying position due to restlessness or lack of cooperation
- Hypertrophic obstructive cardiomyopathy
- Left ventricular thrombus
- Presence of an intra-aortic balloon pump
- Mitral or aortic valve prosthesis, or more than mild native mitral or aortic valve stenosis
- Aortic valve insufficiency grade 2+ or higher
- Mechanical complications of myocardial infarction or uncorrected ventricular or atrial septal defects
- Brain damage or suspected brain damage
- Stroke or transient ischemic attack within past 3 months
- Uncorrectable abnormal blood clotting parameters or active uncontrolled bleeding
- Allergy or intolerance to heparin, aspirin, ADP receptor blockers, contrast media, or nickel
- Known or suspected severe lung disease
- Vascular disease preventing device placement
- Aortic aneurysms, extreme tortuosity, or calcifications posing risk to device placement
- Blood disorders causing fragility or hemolysis
- Participation in another investigational drug or device trial
- Life expectancy less than 1 year due to other health conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, Georgia
Actively Recruiting
2
Tbilisi Heart Center
Tbilisi, Georgia
Actively Recruiting
3
Shamir Medical Center
Be’er Ya‘aqov, Israel
Actively Recruiting
4
Rambam Medical Center
Haifa, Israel
Actively Recruiting
5
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
Actively Recruiting
Research Team
Y
Yelena Lalazar Sr. Director Clinical Affairs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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