The objective of this study is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI. The clinical data may be used to support subsequent regulatory applications and further evaluation of the Supira System.
The Supira System is a temporary (≤ 4 hours) ventricular support device indicated for use during elective or urgent HRPCI performed in hemodynamically stable patients with severe coronary artery disease when a heart team, including a cardiac surgeon, has determined HRPCI is the appropriate therapeutic option.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
15
The Supira System is a minimally invasive, miniaturized percutaneous ventricular assist device (pVAD) system that is intended to provide temporary (≤4 hours) hemodynamic support to patients undergoing a HRPCI procedure. The Catheter is inserted percutaneously via the femoral artery, across the aortic valve, and into the left ventricle under fluoroscopic guidance, with a portion remaining in the ascending aorta. The left ventricle is unloaded by pumping blood from the ventricle into the ascending aorta and systemic circulation.
University of California Davis (UC Davis) Medical Center
Sacramento, California, United States
Piedmont Heart Institute Cardiovascular Research
Atlanta, Georgia, United States
Mount Sinai
New York, New York, United States
Montefiore Medical Center Cardiology Research
The Bronx, New York, United States
Feasibility: Successful initiation and maintenance of hemodynamic support
Successful initiation and maintenance of hemodynamic support without severe hypotension throughout the index procedure. Sustained hypotension is defined as sustained mean arterial pressure (MAP) \< 60 mmHg requiring inotropic/pressor medications or alternative mechanical circulatory support.
Time frame: From device delivery through removal (up to 4 hours)
Safety: Rate of composite major device-related adverse events (MDRAEs), from device insertion through device removal (inclusive of Supira procedure-related SAEs).
MDRAEs are defined as any serious adverse events that are adjudicated by the Clinical Events Committee (CEC) as definitely or probably related to the Supira System.
Time frame: From device delivery through device removal (up to 4 hours)
Technical Success
Rate of technical success, defined as completion of the entire Supira System procedure, including delivery, operation without device malfunction, and successful removal of the Catheter
Time frame: From device delivery through device removal (up to 4 hours)
Procedural Success
Rate of procedural success, defined as the rate of technical success without procedural SAEs.
Time frame: From device delivery through device removal (up to 4 hours)
Rate of composite MDRAEs from device removal through hospital discharge or 72 hours post-procedure, whichever occurs first.
Time frame: From device removal through hospital discharge or 72 hours post-procedure (whichever occurs first) through 30 days post device removal.
Rate of composite MDRAEs from hospital discharge or 72 hours post-procedure (whichever occurs first) through 30 days post device removal.
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Time frame: From hospital discharge or 72 hours post-procedure (whichever occurs first) through 30 days post device removal.
Rate of composite MDRAEs from 30 days to 90 days post device removal.
Time frame: From 30 days to 90 days post device removal.