The Elevate™ EFS study is designed to evaluate the safety and feasibility of the Magenta Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary interventions.
The Elevate™ EFS is planned as a prospective, single-arm, interventional multi-center study enrolling up to 20 subjects. The Magenta Elevate™ Pump is a catheter-mounted, self-expanding and retrievable pump, designed to unload the left ventricle by actively transporting blood from the left ventricle into the ascending aorta. The Magenta Elevate™ is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
The Magenta Elevate™ is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.
Mount Sinai Hospital
New York, New York, United States
New York-Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York, United States
Rate of Major Device-Related Adverse Events (MDRAE)
The rate of Elevate™ related Serious Adverse Events
Time frame: From device delivery through device removal (up to 6 hours)
Rate of successful initiation and maintenance of hemodynamic support without Severe Hypotension
Rate of successful initiation and maintenance of Elevate™ hemodynamic support without Severe Hypotension
Time frame: From device delivery through device removal (up to 6 hours)
Rate of Elevate™ Technical Success
The rate of complete Elevate™ Pump delivery procedures, including operation of the Pump without Device Malfunction and successful retrieval of the Pump
Time frame: From device delivery through device removal (up to 6 hours)
Rate of Elevate™ Procedural Success
The rate of Elevate™ Technical Success without Severe Hypotension
Time frame: From device delivery through device removal (up to 6 hours)
Rate of Major Device-Related Adverse Events (MDRAE)
The rate of Elevate™ related Serious Adverse Events
Time frame: From device removal through hospital discharge (assessed up to 30 days)
Rate of Major Device-Related Adverse Events (MDRAE)
The rate of Elevate™ related Serious Adverse Events
Time frame: From hospital discharge through 30-days post device removal
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