Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock (NCT07293923) | Clinical Trial Compass
RecruitingNot Applicable
Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock
Georgia, Israel10 participantsStarted 2025-11-05
Plain-language 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.
Who can participate
Age range
40 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 co…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Initial Safety
Timeframe: From device delivery through device removal
2
Device Effectiveness
Timeframe: From baseline to 30 minutes of device activation
3
Device Performance
Timeframe: From device delivery through device removal