Magenta Elevate™ device for cardiogenic shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial is a prospective, single-arm interventional feasibility study of the Magenta Elevate™ System in patients with cardiogenic shock due to isolated or predominant left ventricular failure. Participants must have shock of less than 24 hours duration and an LVEF of 15–45% on the day of inclusion, with no more than mild right ventricular dysfunction documented by echocardiography. Patients with other causes of shock (for example sepsis, hypovolemia, pulmonary embolism), severe right heart failure, persistent low oxygen saturation, LV thrombus, existing IABP, or sustained ventricular tachycardia are excluded. The study will monitor initial safety signals, device performance, and short-term effectiveness outcomes following device use.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Study coordinator: Yelena Lalazar Sr. Director Clinical Affairs
• Email: yelenal@magentamed.com
• Phone: +972.50.6829528

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Left Ventricular Support and Advanced Monitoring in AMI–Cardiogenic Shock: Immediate Impella Use and PAC/Monitoring vs Standard Care

  In adults with heart attack-related cardiogenic shock, this trial tests whether using an Impella left ventricular assist device and/or protocolized pulmonary artery catheter monitoring improves survival compared with standard care.

  Recruiting Leipzig Heart Science gGmbH · Leipzig, Saxony · NCT07762560

• CRP Apheresis for infarct-related cardiogenic shock

  This study tests whether selectively removing C-reactive protein with apheresis, in addition to standard care, helps people with cardiogenic shock after a heart attack.

  Recruiting Leipzig Heart Science gGmbH · Leipzig, Saxony · NCT07687017

• Prolonged nasogastric ketone infusion for decompensated heart failure

  This will test whether a continuous nasogastric infusion of a ketone (D‑beta‑hydroxybutyrate) can safely reach target blood levels in adults with severely reduced ejection fraction admitted for acute decompensated heart failure or cardiogenic shock.

  Recruiting Phase 4 Institute for Clinical and Experimental Medicine · Prague, Prague · NCT07527156

• Hemodynamic resuscitation with a Swan-Ganz catheter in cardiogenic shock.

  This will try using a Swan‑Ganz (pulmonary artery) catheter to guide medicines and fluids in adults who have cardiogenic shock after a heart attack.

  Recruiting Bach Mai Hospital · Hanoi · NCT07062744

• Initiation and Titration of GDMT with Impella 5.5 in Heart Failure with Cardiogenic Shock

  This study tests a device-plus-drug strategy using the Impella 5.5 alongside optimized guideline-directed medical therapy to see if heart recovery improves in adults with decompensated heart failure and cardiogenic shock.

  Recruiting at 2 sites Abiomed Inc. · Tampa, Florida and 16 other locations · NCT06965504

• Impact of lower vasopressor use on survival in patients with heart failure on ECMO

  This study is testing if using less vasopressor medication can help adults with heart failure on ECMO survive better over 30 days.

  Recruiting Beijing Anzhen Hospital · Beijing, Beijing Municipality · NCT06862700

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.