RecruitingNot ApplicableNCT07293923

Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock

Clinical Feasibility Study of the Magenta Elevate™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients With Cardiogenic Shock


Sponsor

Magenta Medical Ltd.

Enrollment

10 participants

Start Date

Nov 5, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This feasibility study evaluates a new mechanical heart support device called the Magenta Elevate in patients experiencing cardiogenic shock — a life-threatening condition where the heart suddenly cannot pump enough blood to meet the body's needs. **You may be eligible if...** - You are experiencing cardiogenic shock that started within the past 24 hours - Your heart's pumping function (left ventricular ejection fraction) is between 15% and 45% - You have no more than mild right-sided heart failure - You or your representative is able to sign informed consent **You may NOT be eligible if...** - Your shock is caused by something other than heart failure (such as infection, low blood volume, blood clot, or allergic reaction) - Your blood oxygen level is very low and cannot be improved with supplemental oxygen or a breathing tube - You have severe right heart failure - You have a dangerous heart rhythm (sustained VT) at the time of enrollment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEElevate™ System

The Elevate™ percutaneous Left Ventricular Assist Device System


Locations(5)

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, Georgia

Tbilisi Heart Center

Tbilisi, Georgia

Shamir Medical Center

Be’er Ya‘aqov, Israel

Rambam Medical Center

Haifa, Israel

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

View Full Details on ClinicalTrials.gov

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NCT07293923


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