Magenta Elevate™ device for cardiogenic shock

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

This trial tries the Magenta Elevate™ device to see if it can safely support people with cardiogenic shock caused by left ventricular failure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 40 Years to 89 Years
• Sex: All
• Sponsor: Magenta Medical Ltd. (Industry-sponsored)
• Locations: 5 sites (Tbilisi and 4 other locations)
• Trial ID: NCT07293923 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients with cardiogenic shock of under 24 hours duration, left ventricular ejection fraction between 15% and 45%, no more than mild right ventricular dysfunction, and who can give informed consent.

Not a fit: Patients with shock from non-cardiac causes (sepsis, hypovolemia, pulmonary embolism), significant right ventricular failure, low oxygen saturation uncorrected by support, LV thrombus, an implanted IABP, or sustained ventricular tachycardia are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, the device could provide a new option to stabilize patients with left-ventricular cardiogenic shock and improve early recovery while avoiding more invasive support.

How similar studies have performed: Other short-term left ventricular support devices have shown benefit in selected cardiogenic shock patients, but the Magenta Elevate™ System's safety and performance are being tested here in an initial feasibility setting.

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.

Where this trial is running

Tbilisi and 4 other locations

• 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)
• Tel-Aviv Sourasky Medical Center — Tel Aviv, Israel (Recruiting)

Study contacts

• Study coordinator: Yelena Lalazar Sr. Director Clinical Affairs

Conditions Cardiogenic Shock; Heart Failure; Acute Myocardial Infarction