NCT07293923

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
19mo left

Started Nov 2025

Typical duration for not_applicable

Geographic Reach
2 countries

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Nov 2025Feb 2028

Study Start

First participant enrolled

November 5, 2025

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2028

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

2.2 years

First QC Date

November 24, 2025

Last Update Submit

July 15, 2026

Conditions

Heart FailureAcute Myocardial Infarction (AMI)Cardiogenic Shock

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Cardiogenic shock

EXPERIMENTAL

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

Device: Elevate™ System

Interventions

Elevate™ SystemDEVICE

The Elevate™ percutaneous Left Ventricular Assist Device System

Cardiogenic shock

Eligibility Criteria

Age40 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiogenic shock of less than 24 hours duration.
  • Signed informed consent.

You may not qualify if:

  • 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.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, Georgia

RECRUITING

Tbilisi Heart Center

Tbilisi, Georgia

RECRUITING

Shamir Medical Center

Be’er Ya‘aqov, Israel

RECRUITING

Rambam Medical Center

Haifa, Israel

RECRUITING

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Beilinson Medical Center

Petah Tikva, Israel

RECRUITING

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Shock, CardiogenicHeart Failure

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Study Officials

  • Yelena Lalazar

    Magenta Medical

    STUDY DIRECTOR

Central Study Contacts

Yelena Lalazar Sr. Director Clinical Affairs

CONTACT

+972.50.6829528yelenal@magentamed.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 19, 2025

Study Start

November 5, 2025

Primary Completion (Estimated)

January 30, 2028

Study Completion (Estimated)

February 28, 2028

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

IL(6)GE(2)