Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock

July 15, 2026 updated by: Magenta Medical Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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
      • Kfar Saba, Israel
        • Recruiting
        • Meir Medical Center
        • Contact:
      • Petah Tikva, Israel
        • Recruiting
        • Beilinson medical center
        • Contact:
      • Ramat Gan, Israel
      • Tel Aviv, Israel
        • Recruiting
        • Tel-Aviv Sourasky Medical Center
        • Contact:
          • Yishay Szekely, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Initial Safety
Time Frame: From device delivery through device removal
The rate of the composite of Major Device-Related Adverse Events
From device delivery through device removal
Device Effectiveness
Time Frame: From baseline to 30 minutes of device activation

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
Time Frame: From device delivery through device removal
  • 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Magenta Medical Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yelena Lalazar, Magenta Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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