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; Thecriteria for refractory cardiogenic shock are: despite adequate doses of twovasoactive drugs and treatment of the underlying cause, there is still evidence oftissue hypoperfusion;

3. The subject can understand the purpose of the trial, voluntarily participate andsign the written informed consent form reviewed and approved by the ethicscommittee; the subject agrees to complete the follow-up in accordance with theprotocol requirements.

Exclusion Criteria:

1. Right heart failure that meets any of the following conditions: a Central venous pressure-capillary wedge pressure ≥10mmHg; b Central venouspressure-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, autoimmunehemolytic anemia or other diseases that cause hemolysis;

13. Cardiopulmonary resuscitation lasting more than 15 minutes within 24 hours beforecatheter pump implantation;

14. Ventricular tachycardia or ventricular fibrillation is ineffective with drugtreatment;

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 asrequired by the protocol;

21. Pregnant or lactating women, female subjects with potential fertility but unable orunwilling to use effective contraceptive measures during the study;

22. Subjects who have participated in other clinical trials within 3 months or arecurrently participating in other clinical trials;

23. Other situations that the investigator believes are not suitable for clinicaltrials.

For Formal Research Phase

Inclusion Criteria:

1. Age 18-75 years old;

2. Low cardiac output syndrome or increased filling pressure after regular continuouspumping of 1 high-dose or 2 medium-dose inotropic drugs within 48 hours aftercardiopulmonary bypass was removed during cardiac surgery. The specific criteria areas 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:

2. Central venous pressure-capillary wedge pressure ≥10mmHg;

3. Central venous pressure-pulmonary artery diastolic pressure ≥10mmHg;

4. Cardiac ascites.

5. Any peripheral vascular disease that prevents the placement of the trial device;

6. Left or right ventricular thrombus;

7. Aortic valve regurgitation, echocardiographic grade ≥2+;

8. Aortic valve stenosis, valve area ≤1.5cm2;

9. Presence of mechanical aortic valve;

10. Hypertrophic or obstructive cardiomyopathy;

11. Untreated ventricular septal or atrial septal defect;

12. Patent foramen ovale;

13. Mechanical complications of acute myocardial infarction;

14. Suffering from diseases that cause increased blood cell fragility or hemolysis;

15. Cardiopulmonary resuscitation lasting more than 15 minutes within 24 hours beforecatheter pump implantation;

16. Sustained or non-sustained ventricular tachycardia or ventricular fibrillation thatis unresponsive to drug treatment;

17. Renal failure, serum creatinine ≥3.5mg/dl or blood urea nitrogen ≥100mg/dl;

18. Liver failure, total bilirubin ≥5mg/dl;

19. Allergy or intolerance to heparin;

20. Other cardiac assist devices other than IABP have been implanted;

21. Active systemic infection;

22. Refuse to sign the informed consent form or fail to complete follow-up as requiredby the protocol;

23. Pregnant or lactating women, female subjects with potential fertility but unable orunwilling to use effective contraceptive measures during the study;

24. Subjects who are participating in other clinical trials and have not yet reached theendpoints of the trial;

25. Other situations that the investigator believes are not suitable for clinicaltrials.