Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock
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.
| Condition(s) | Cardiogenic Shock, Heart Failure, Acute Myocardial Infarction (AMI) |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 | 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 i |
| Ages | 40 Years to 89 Years |
| Sex | All |
| Lead sponsor | Magenta Medical Ltd. |
| Locations | Tbilisi, Georgia; Tbilisi, Georgia; Be’er Ya‘aqov, Israel; Haifa, Israel; Tel Aviv, Israel |
| Start date | 2025-11-05 |
| NCT ID | NCT07293923 |
| Official listing | https://clinicaltrials.gov/study/NCT07293923 |