IMPACT EU Post-Market Clinical Follow-Up Study

Inclusion Criteria:

1. Hemodynamically stable patients undergoing one (1) of the following cardiac surgeryprocedures on CPB including aortic cross-clamping and cardioplegic arrest

• Isolated CABG

• Isolated mitral valve repair or replacement (MVR)

• Isolated aortic valve repair or replacement (AVR)

• At lest two of the following: CABG, MVR, AVR, or tricuspid valve repair orreplacement (TVR)

2. LVEF within 30 days before surgery of either:

• ≤25% measured by echocardiogram or

• LVEF ≤35% as above for patients with significant mitral regurgitation (MR 3+ or 4+; see definition) and planned corrective mitral valve surgery (including MVreplacement or repair)

3. Age 18 years or older

4. Subject has signed informed consent form and is willing and able to attend allfollow-up visits and to perform all tests.

5. Patient is eligible to receive the Impella 5.5 as per the current IFU.

Exclusion Criteria:

1. Salvage operation (cardiac arrest within 24 hours prior to index surgery)

2. Unresponsive state within 24 hours of the time of surgery

3. Any inotrope within 72 hours of surgery

4. Any mechanical MCS device (such as IABP, ECMO, Impella®, CentriMag™ or TandemHeart®)in place prior to informed consent

5. RV dysfunction requiring mechanical or inotropic support preoperatively and/orlikely to be needed postoperatively

6. Index procedures requiring total circulatory arrest (TCA), such as aortic archreplacement, planned durable LVAD, durable RVAD, planned right-sided temporarymechanical support of any kind, total artificial heart (TAH), cardiactransplantation, pericardiectomy, pulmonary thromboendarterectomy and septalmyectomy

7. Restrictive or obstructive cardiomyopathy, constrictive pericarditis, restrictivepericarditis, pericardial tamponade or other conditions in which cardiac output isdependent on venous return

8. Ventricular septal defect (VSD)

9. Stroke within 30 days of the index cardiac surgical procedure

10. Prior mantle field chest irradiation

11. Prior solid organ or hematologic transplantation (heart, kidney, liver, lung,pancreas, bone marrow) or durable LVAD

12. History of chronic dialysis

13. Pre-existing liver dysfunction defined as Child-Pugh Class B or C

14. Pre-existing pulmonary disease requiring home oxygen, or "severe pulmonary disease"determined by enrolling investigator

15. Systemic active infection or evidence of systemic bacterial, fungal or viralinfection within 72 hours before surgery (blood culture positive with leukocytosis)

16. Confirmed COVID-19 infection within two (2) weeks prior to operation

17. Pregnant or planning pregnancy within next 12 months. NOTE: Female patients ofchildbearing potential need to have a negative pregnancy test performed within 14days prior to intervention.

18. Participation in the active treatment or follow-up phase of another interventionalclinical trial of an investigational drug or device which has not reached itsprimary endpoint

19. Known contraindication to heparin; History of bleeding diathesis or knowncoagulopathy or will refuse blood transfusions

20. Inability to perform aortic cross-clamp, such as due to porcelain aorta

21. Any contraindication or condition that would prevent the ability to place Impella 5.5® (per current IFU), including LV thrombus and/or presence of a mechanical aorticvalve

22. Any organ condition, concomitant disease (e.g., psychiatric illness, current severealcoholism or current drug abuse, cancer, hepatic or kidney disease), with lifeexpectancy of ≤2 years or other abnormality that itself or the treatment of which,could interfere with the conduct of the trial or that, in the opinion of theinvestigator would pose an unacceptable risk to the subject in the trial.

23. Subject has other medical, social or psychological problems that, in the opinion ofthe investigator, compromises the subject's ability to give written informed consentand/or to comply with trial procedures, including patients under guardianship

24. Any subject considered to be part of a vulnerable population (as per ISO 14155)