NCT07293923 Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock
| NCT ID | NCT07293923 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Magenta Medical Ltd. |
| Condition | Cardiogenic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-11-05 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2025-11-05 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Yelena Lalazar
STUDY DIRECTOR
Magenta Medical
Frequently Asked Questions
Who can join the NCT07293923 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 89 Years, studying Cardiogenic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07293923 currently recruiting?
Yes, NCT07293923 is actively recruiting participants. Contact the research team at yelenal@magentamed.com for enrollment information.
Where is the NCT07293923 trial being conducted?
This trial is being conducted at Tbilisi, Georgia, Tbilisi, Georgia, Be’er Ya‘aqov, Israel, Haifa, Israel and 1 additional location.
Who is sponsoring the NCT07293923 clinical trial?
NCT07293923 is sponsored by Magenta Medical Ltd.. The principal investigator is Yelena Lalazar at Magenta Medical. The trial plans to enroll 10 participants.