Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-89
SponsorMagenta Medical Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Elevate™ System
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov