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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Cardiogenic Shock; Acute Myocardial Infarction (AMI)
• Intervention / Treatment: Device: Elevate™ System

Detailed Description

The Elevate™ CS Clinical Feasibility Study is planned as a prospective, single-arm, interventional study.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yelena Lalazar Sr. Director Clinical Affairs; Phone Number: +972.50.6829528; Email: yelenal@magentamed.com

Study Locations

• Georgia
  • Tbilisi, Georgia
    • Recruiting
    • Israeli-Georgian Medical Research Clinic Helsicore
    • Contact: Irakli Gogorishvili, MD
  • Tbilisi, Georgia
    • Recruiting
    • Tbilisi Heart Center
    • Contact: Archil Chukhrukidze, MD
• Israel
  • Be’er Ya‘aqov, Israel
    • Recruiting
    • Shamir Medical Center
    • Contact: Eran Kalmanovich, MD
  • Haifa, Israel
    • Recruiting
    • Rambam Medical Center
    • Contact: Roni Abbo, MD
  • Tel Aviv, Israel
    • Recruiting
    • Tel-Aviv Sourasky Medical Center
    • Contact: Yishay Szekely, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiogenic shock; Acute myocardial infarction or acutely decompensated heart failure and cardiogenic shock patients	Device: Elevate™ System; The Elevate™ percutaneous Left Ventricular Assist Device System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial Safety	The rate of the composite of Major Device-Related Adverse Events	From device delivery through device removal
Device Effectiveness	Hemodynamic stability and/or improvement from baseline following device activation, defined as: Number (percentage) of patients with MAP>60mmHg; Improvement in MAP	From baseline to 30 minutes of device activation
Device Performance	Rate of successful delivery of the Elevate™ System; Rate of successful deployment of the Elevate™ System; Rate of successful use of the Elevate™ System; Rate of successful retrieval of the Elevate™ System	From device delivery through device removal

Collaborators and Investigators

• Sponsor: Magenta Medical Ltd.
• Investigators: Study Director: Yelena Lalazar, Magenta Medical

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Shock; Pathological Conditions, Signs and Symptoms; Heart Failure; Shock, Cardiogenic
• Other Study ID Numbers: DRD00691

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No