Cardiogenic ShockNCT07293923
Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock
A study testing Elevate™ System in people with Cardiogenic Shock and Heart Failure, run by Magenta Medical Ltd. at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- Cardiogenic Shock, Heart Failure, Acute Myocardial Infarction (AMI)
- What is being tested?
- Elevate™ System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 5 Nov 2025to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
Israel6 sites, 6 recruiting
- Recruiting
Shamir Medical Center
Be’er Ya‘aqov
Eran Kalmanovich, MD
- Recruiting
Rambam Medical Center
Haifa
Roni Abbo, MD
- Recruiting
Meir Medical Center
Kfar Saba
Prof. Abid R. Assali, +972-97472573, aassali@clalit.org.il
- Recruiting
Beilinson Medical Center
Petah Tikva
Prof. Katya Orvin, +972-39372211, katiao@clalit.org.il
- Recruiting
Sheba Medical Center
Ramat Gan
Dr. Assi Milwidsky, +972-35303030, Assi.Milwidsky@sheba.health.gov.il
- Recruiting
Tel-Aviv Sourasky Medical Center
Tel Aviv
Yishay Szekely, MD
Georgia2 sites, 2 recruiting
- Recruiting
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi
Irakli Gogorishvili, MD
- Recruiting
Tbilisi Heart Center
Tbilisi
Archil Chukhrukidze, MD
About this study
Official title: 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.
Read the detailed description
The Elevate™ CS Clinical Feasibility Study is planned as a prospective, single-arm, interventional study.
- Being tested
- Elevate™ System
- Medical subject headings
- Shock, Cardiogenic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elevate™ SystemDevice
The Elevate™ percutaneous Left Ventricular Assist Device System
| Study group | Role | What they receive |
|---|---|---|
| Cardiogenic shock | Experimental | Acute myocardial infarction or acutely decompensated heart failure and cardiogenic shock patients Receives: Device: Elevate™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial Safety
The rate of the composite of Major Device-Related Adverse Events
Measured: 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
Measured: 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
Measured: From device delivery through device removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start5 Nov 2025
- Primary completion30 Jan 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Magenta Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yelena Lalazar, Study director, Magenta Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293923
- Sponsor's protocol ID
- DRD00691
- Status last verified
- Jul 2026
- First submitted
- 24 Nov 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility Study of the Magenta Elevate™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients With Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT07293923
- Acronym / sponsor ID
- DRD00691
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Magenta Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Elevate™ CS Clinical Feasibility Study is planned as a prospective, single-arm, interventional study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiogenic shock | Experimental | Device: Elevate™ SystemAcute myocardial infarction or acutely decompensated heart failure and cardiogenic shock patients |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elevate™ SystemThe Elevate™ percutaneous Left Ventricular Assist Device System | Device | Cardiogenic shock |
Primary outcome
Initial Safety
Time frame: From device delivery through device removal
The rate of the composite of Major Device-Related Adverse Events
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Cardiogenic Shock
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Cardiogenic Shock Working Group Registry
Cardiogenic Shock
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Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
AMI Cardiogenic Shock
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CRP Apheresis in Infarct-Related Cardiogenic Shock
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Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yelena Lalazar study director
Magenta Medical
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elevate™ System in people with Cardiogenic Shock and Heart Failure, run by Magenta Medical Ltd. at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Israel, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yelena Lalazar Sr. Director Clinical Affairs (+972.50.6829528, yelenal@magentamed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial Safety (time frame: From device delivery through device removal). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026; AzTrials last refreshed its copy on 3 Nov 2026.