Actively Recruiting
Clinical Feasibility Study of the Magenta Elevate17 Percutaneous Left Ventricular Assist Device System in Patients With Cardiogenic Shock
Led by Magenta Medical Ltd. · Updated on 2026-02-27
10
Participants Needed
5
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Magenta Elevate17 percutaneous Left Ventricular Assist Device (pLVAD) system in patients experiencing cardiogenic shock due to isolated or predominant left ventricular failure, particularly those with acute myocardial infarction or acutely decompensated heart failure. This prospective, single-arm, interventional feasibility study aims to assess the initial safety, effectiveness, and performance of the device. Participants will receive the Elevate17 System, a device intended to assist left ventricular function. The study includes patients with cardiogenic shock of less than 24 hours duration, left ventricular ejection fraction between 15% and 45%, and no more than mild right ventricular dysfunction. The device will be delivered and activated, with assessments made from delivery through removal and up to 30 minutes of activation. During the study, researchers will monitor safety from device placement through removal, effectiveness from baseline to 30 minutes of activation, and overall device performance during the same period. Participants will be evaluated using echocardiography and other clinical assessments to track heart function and device impact. The study begins in November 2025 and ends in October 2026, with participants followed closely during device use and removal.
CONDITIONS
Brief Title
Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cardiogenic shock of less than 24 hours duration
- Left ventricular ejection fraction less than 45% and greater than 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
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, uncorrected by oxygen or intubation
- Sustained ventricular tachycardia at enrollment
- Significant right heart failure or right ventricular dysfunction
- Awake patient unable to remain stable due to restlessness or lack of cooperation
- Hypertrophic obstructive cardiomyopathy
- Left ventricular thrombus
- Presence of an intra-aortic balloon pump (IABP)
- Mitral and/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 3 months
- Uncorrectable abnormal coagulation 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 pathology posing risk to device placement
- Disorders causing blood cell 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From device delivery through device removal
Participants receive the Elevate™ percutaneous Left Ventricular Assist Device as part of treatment for cardiogenic shock.
1 visit for device placement and removal
Duration - Up to 30 minutes post device activation
Participants are monitored after device removal to assess safety and device performance.
1 follow-up visit
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
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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