Clinical Feasibility Study of the Magenta Elevate™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients With Cardiogenic Shock
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 89
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Georgia
Israeli-Georgian Medical Research Clinic Helsicore
RECRUITING
Tbilisi
Tbilisi Heart Center
RECRUITING
Tbilisi
Israel
Shamir Medical Center
RECRUITING
Be’er Ya‘aqov
Rambam Medical Center
RECRUITING
Haifa
Tel-Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Contact Information
Primary
Yelena Lalazar Sr. Director Clinical Affairs
yelenal@magentamed.com
+972.50.6829528
Time Frame
Start Date: 2025-11-05
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 10
Treatments
Experimental: Cardiogenic shock
Acute myocardial infarction or acutely decompensated heart failure and cardiogenic shock patients
Related Therapeutic Areas
Sponsors
Leads: Magenta Medical Ltd.