Early Feasibility Study of the Supira System in Patients Undergoing HRPCI

Inclusion criteria

• ✓. Age ≥18 and ≤90 years
• ✓. Subject is hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is needed, as determined by the institutional heart team
• ✓. Informed consent granted by the patient or legally authorized representative
• ✓. Cardiogenic shock or acutely decompensated pre-existing chronic heart failure
• ✓. Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
• ✓. Evidence of left ventricular thrombus as assessed by Transthoracic Echocardiogram (TTE)
• ✓. Aortic valvular disease or regurgitation categorized as moderate or greater (≥2+ on a 4-grade scale as assessed on TTE)
• ✓. Aortic stenosis categorized as moderate or greater (gradient \>20 mmHg or valve area \<1.5 cm\^2 as assessed on TTE)