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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Elevate™ System
DeviceThe Elevate™ percutaneous Left Ventricular Assist Device System
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Cardiogenic shockExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Initial Safety
The rate of the composite of Major Device-Related Adverse Events
Time frame
From device delivery through device removal2
Device Effectiveness
Hemodynamic stability and/or improvement from baseline following device activation, defined as: * Number (percentage) of patients with MAP\>60mmHg * Improvement in MAP
Time frame
From baseline to 30 minutes of device activation3
Device Performance
* Rate of successful delivery of the Elevate™ System * Rate of successful deployment of the Elevate™ System * Rate of successful use of the Elevate™ System * Rate of successful retrieval of the Elevate™ System
Time frame
From device delivery through device removalSponsors and contacts
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Source ClinicalTrials.gov