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Recruiting NCT07293923

Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock

No phase Interventional Cardiogenic Shock Heart Failure Acute Myocardial Infarction (AMI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Elevate™ System.
Who it may be relevant to
Registry conditions: Cardiogenic Shock, Heart Failure, Acute Myocardial Infarction (AMI). Basic parameters: 40 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Georgia, Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Feasibility Study of the Magenta Elevate™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients With Cardiogenic Shock

Overview

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.

Interventions

  • Device Elevate™ System
    The Elevate™ percutaneous Left Ventricular Assist Device System

Primary outcome measures

  • Initial Safety [Time frame: From device delivery through device removal]
  • Device Effectiveness [Time frame: From baseline to 30 minutes of device activation]
  • Device Performance [Time frame: From device delivery through device removal]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Israel · 6 centers
  • Shamir Medical Center — Be’er Ya‘aqov
  • Rambam Medical Center — Haifa
  • Meir Medical Center — Kfar Saba
  • Beilinson Medical Center — Petah Tikva
  • Sheba Medical Center — Ramat Gan
  • Tel-Aviv Sourasky Medical Center — Tel Aviv
Georgia · 2 centers
  • Israeli-Georgian Medical Research Clinic Helsicore — Tbilisi
  • Tbilisi Heart Center — Tbilisi

Identifiers

NCT: NCT07293923 · DRD00691

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗