IMpella-Protected cArdiaC Surgery Trial (IMPACT)

Inclusion Criteria:

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

• Isolated CABG

• Isolated mitral valve repair or mitral valve replacement (MVR)

• Isolated biological aortic valve replacement (AVR)

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

• Additional concomitant procedures permitted:

1. Atrial septal defect (ASD) or patent foramen ovale (PFO) repair or closure

2. Atrial fibrillation ablation procedures

3. Left atrial ablation (all forms including complete left/right side CoxMaze)

4. Coronary endarterectomy

5. LVEF within 30 days before surgery of either:

• ≤25% measured by echocardiogram or cardiac MRI, OR

• LVEF ≤35%, measured as above, for patients with significant mitralregurgitation (MR 3+ or 4+) and planned corrective mitral valve surgery (including MV replacement or repair)

• Any subject with EF <20% must have viability assessment performed toassess CABG candidacy (MRI preferred)

3. Age 18 years or older

4. Subject (or subject's LAR, if allowed by IRB) has signed Informed Consent Form

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 MCS device (such as IABP, ECMO, Impella®, CentriMag™ or TandemHeart®) in placeat time of informed consent and less than 24 hours prior to index study procedure

5. RV dysfunction requiring mechanical or inotropic support pre-operatively and/orlikely to be needed post-operatively

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 weeks prior to operation

17. Suspected or known pregnancy

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 inability to place Impella 5.5 (per the IFU), including LVthrombus and/or presence of a mechanical aortic valve

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 whichcould interfere with the conduct of the trial or that, in the opinion of theinvestigator and/or Sponsor's medical monitor, would pose an unacceptable risk tothe patient in the trial.

23. Patient 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

24. Patient belongs to a vulnerable population [Vulnerable patient populations aredefined as individuals with mental disability, persons in nursing homes, children,impoverished persons, homeless persons, nomads, refugees and those permanentlyincapable of giving informed consent. Vulnerable populations also may includemembers of a group with a hierarchical structure such as university students,subordinate hospital and laboratory personnel, employees of the Sponsor, members ofthe armed forces and persons kept in detention]