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New treatment option for Cardiogenic Shock
Official title Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock
ClinicalTrials.gov ID: NCT07293923
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 89
You may be able to join if
- Cardiogenic shock of less than 24 hours duration.
- Left ventricular ejection fraction \ 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.
You likely can't join 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...
- 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.
See the full eligibility criteria
- Cardiogenic shock of less than 24 hours duration.
- Left ventricular ejection fraction \ 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.
- 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.
- people 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 \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tbilisi, Georgia
- Be’er Ya‘aqov, Israel
- Haifa, Israel
- Kfar Saba, Israel
- Petah Tikva, Israel
- Ramat Gan, Israel
- Tel Aviv, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tbilisi, Georgia; Be’er Ya‘aqov, Israel; Haifa, Israel; Kfar Saba, Israel; Petah Tikva, Israel; Ramat Gan, Israel and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.