An Interventional Left Ventricular Assist System for Cardiogenic Shock

For Pre-trial Phase Inclusion Criteria: 1. Age 18-75 years old; 2. Refractory cardiogenic shock as determined by the cardiac MDT expert group; The criteria for refractory cardiogenic shock are: despite adequate doses of two vasoactive drugs and treatment of the underlying cause, there is still evidence of tissue hypoperfusion; 3. The subject can understand the purpose of the trial, voluntarily participate and sign the written informed consent form reviewed and approved by the ethics committee; the subject agrees to complete the follow-up in accordance with the protocol requirements. Exclusion Criteria: 1. Right heart failure that meets any of the following conditions: a Central venous pressure-capillary wedge pressure ≥10mmHg; b Central venous pressure-pulmonary artery diastolic pressure ≥10mmHg; c Cardiac tamponade. 2. Any peripheral vascular disease that prevents the placement of the trial device; 3. Left or right ventricular thrombus; 4. Aortic valve regurgitation, echocardiographic grade ≥2+; 5. Aortic valve stenosis, valve area ≤1.5cm2; 6. Aortic valve calcification; 7. Presence of mechanical aortic valve; 8. Hypertrophic or obstructive cardiomyopathy; 9. Untreated ventricular septal or atrial septal defect; 10. Patent foramen ovale; 11. Mechanical complications of acute myocardial infarction; 12. Presence of hereditary spherocytosis, hereditary elliptocytosis, autoimmune hemolytic anemia or other diseases that cause hemolysis; 13. Cardiopulmonary resuscitation lasting more than 15 minutes within 24 hours before catheter pump implantation; 14. Ventricular tachycardia or ventricular fibrillation is ineffective with drug treatment; 15. Renal failure, serum creatinine ≥309.4umol/l or blood urea nitrogen ★ ≥35.7mmol/l); 16. Liver failure (total bilirubin ≥85.5umol/l); 17. Allergy or intolerance to heparin; 18. Presence of any cardiac assist device; 19. Presence of active systemic infection; 20. Refusing to sign the informed consent form or failing to complete follow-up as required by the protocol; 21. Pregnant or lactating women, female subjects with potential fertility but unable or unwilling to use effective contraceptive measures during the study; 22. Subjects who have participated in other clinical trials within 3 months or are currently participating in other clinical trials; 23. Other situations that the investigator believes are not suitable for clinical trials. For Formal Research Phase Inclusion Criteria: 1. Age 18-75 years old; 2. Low cardiac output syndrome or increased filling pressure after regular continuous pumping of 1 high-dose or 2 medium-dose inotropic drugs within 48 hours after cardiopulmonary bypass was removed during cardiac surgery. The specific criteria are as follows; The drugs, doses and time of 1 high-dose or 2 medium-dose inotropic drugs are as follows: Epinephrine: medium dose (\<0.03 μg/kg/min), continuous pumping ≥15 minutes High dose (≥0.03 μg/kg/min), continuous pumping ≥15 minutes; Dobutamine: medium dose (\<5μg/kg/min), continuous pumping ≥15 minutes High dose (≥5μg/kg/min), continuous pumping ≥15 minutes; Milrinone: medium dose (\<0.3 μg/kg/min), continuous pumping ≥120 minutes High dose (≥0.3 μg/kg/min), continuous pumping ≥120 minutes; Low cardiac output syndrome: cardiac index 1.3≤CI≤2.2 L/min/m2; Increased filling pressure: pulmonary capillary wedge pressure: 20≤PCWP≤30mmHg or pulmonary artery systolic pressure: 25≤PAP≤35mmHg 3) The subject can understand the purpose of the trial, voluntarily participate and sign the informed consent form reviewed and approved by the ethics committee; the subject agrees to complete the follow-up in accordance with the protocol requirements. Exclusion Criteria: 1. Right heart failure that meets any of the following conditions: 1. Central venous pressure-capillary wedge pressure ≥10mmHg; 2. Central venous pressure-pulmonary artery diastolic pressure ≥10mmHg; 3. Cardiac ascites. 2. Any peripheral vascular disease that prevents the placement of the trial device; 3. Left or right ventricular thrombus; 4. Aortic valve regurgitation, echocardiographic grade ≥2+; 5. Aortic valve stenosis, valve area ≤1.5cm2; 6. Presence of mechanical aortic valve; 7. Hypertrophic or obstructive cardiomyopathy; 8. Untreated ventricular septal or atrial septal defect; 9. Patent foramen ovale; 10. Mechanical complications of acute myocardial infarction; 11. Suffering from diseases that cause increased blood cell fragility or hemolysis; 12. Cardiopulmonary resuscitation lasting more than 15 minutes within 24 hours before catheter pump implantation; 13. Sustained or non-sustained ventricular tachycardia or ventricular fibrillation that is unresponsive to drug treatment; 14. Renal failure, serum creatinine ≥3.5mg/dl or blood urea nitrogen ≥100mg/dl; 15. Liver failure, total bilirubin ≥5mg/dl; 16. Allergy or intolerance to heparin; 17. Other cardiac assist devices other than IABP have been implanted; 18. Active systemic infection; 19. Refuse to sign the informed consent form or fail to complete follow-up as required by the protocol; 20. Pregnant or lactating women, female subjects with potential fertility but unable or unwilling to use effective contraceptive measures during the study; 21. Subjects who are participating in other clinical trials and have not yet reached the endpoints of the trial; 22. Other situations that the investigator believes are not suitable for clinical trials.