Phitys I™ Percutaneous Left Ventricular Assist System Study

Exclusion Criteria

• •1. Pre-procedure cardiac arrest within 24 hours of enrolment requiring CPR;
• •2. Pre-procedure ST-segment myocardial infarction within 24 hours of enrolment;
• •3. Patient is in cardiogenic shock;
• •4. Mural thrombus in the left ventricle;
• •5. Post-infarction ventricular septal rupture, or atrial septal or ventricular septal defects;
• •6. The presence of mechanical aortic or mitral valve or heart constrictive device;
• •7. The presence of aortic stenosis (aortic orifice area ≤1.5cm²)；
• •8. The presence of moderate to severe aortic or mitral or tricuspid insufficiency;
• •9. The presence of severe peripheral vascular disease that would preclude the placement of the percutaneous mechanical circulatory assist device;
• •10. Severe aortic diseases such as aortic dissection and aortic aneurysm;
• •11. Active infective endocarditis or other active infections;
• •12. Chronic renal insufficiency (creatinine clearance≤30ml/min);
• •13. Liver dysfunction (elevation of liver enzymes and bilirubin levels to ≥3xULN or INR≥2);
• •14. The presence of uncorrectable abnormal coagulation (platelet count≤75,000/mm\^3 or INR≥2.0 or fibrinogen≤1.50 g/l);
• •15. The presence of uncorrected moderate to severe anemia (hemoglobin \<90 g/L);
• •16. History of stroke or TIA within 1 month of enrolment;
• •17. Allergy or intolerance to contrast media, anticoagulant and antiplatelet drugs (e.g., bivalirudin, low molecular heparin, aspirin, clopidogrel, Ticagrelor, etc.);
• •18. Participation in clinical trials of other drugs or medical devices prior to enrollment that have not yet reached the primary outcome of research;
• •19. Patient with poor compliance and could not complete the study as required determined by the investigator.