Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock

NCT ID: NCT07293923

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-05
• Study Completion Date: 2026-10-30

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.

Detailed Description

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

Conditions

Cardiogenic Shock; Heart Failure; Acute Myocardial Infarction (AMI)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cardiogenic shock

Acute myocardial infarction or acutely decompensated heart failure and cardiogenic shock patients

Group Type: EXPERIMENTAL

Elevate™ System

Intervention Type: DEVICE

The Elevate™ percutaneous Left Ventricular Assist Device System

Interventions

Elevate™ System

The Elevate™ percutaneous Left Ventricular Assist Device System

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Magenta Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yelena Lalazar

Role: STUDY_DIRECTOR

Magenta Medical

Locations

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, , Georgia

Site Status: RECRUITING

Tbilisi Heart Center

Tbilisi, , Georgia

Site Status: RECRUITING

Countries

Georgia

Central Contacts

Yelena Lalazar Sr. Director Clinical Affairs

Role: CONTACT

Phone: +972.50.6829528

Email: yelenal@magentamed.com

Facility Contacts

Irakli Gogorishvili, MD

Role: primary

Archil Chukhrukidze, MD

Role: primary

Other Identifiers

DRD00691

Identifier Type: -

Identifier Source: org_study_id