IMpella-Protected cArdiaC Surgery Trial (IMPACT) (IMPACT)

This is an interventional treatment trial for Left Ventricular Dysfunction focused on measuring High-risk Cardiac Surgery, Low pre-operative left ventricular ejection fraction, Cardiopulmonary bypass (CPB), Temporary Mechanical Circulatory System (MCS) Read More

Inclusion Criteria:

1. Patients undergoing one of the following elective or urgent (within 24 hours from admission) cardiac surgery procedures on CPB including aortic cross-clamping and cardioplegic arrest:

   • Isolated CABG
   • Isolated mitral valve repair or replacement (MVR)
   • Mitral and tricuspid valve repair or replacement (MVR/TVR)
   • CABG and mitral valve repair or replacement (CABG/MVR)
   • CABG and mitral valve repair or replacement and tricuspid valve repair or replacement (CABG/MVR/TVR)
   • CABG and tricuspid valve repair or replacement (CABG/TVR)

   • Additional concomitant procedures permitted:

     1. Atrial septal defect (ASD) or patent foramen ovale (PFO) repair or closure
     2. Closure or excision of left atrial appendage (LAA)
     3. Left atrial ablation (all forms including complete left/right side Cox Maze)
     4. Coronary endarterectomy

2. LVEF within 30 days before surgery of either:

   • ≤30% measured by echocardiogram or
   • LVEF ≤35% as above for patients with significant mitral regurgitation (MR 3+ or 4+) and planned corrective mitral valve surgery (including MV replacement or repair)
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 MCS device (such as IABP, ECMO, Impella®, CentriMag™ or TandemHeart®) in place prior to informed consent
4. RV dysfunction requiring mechanical or inotropic support pre-operatively and/or likely to be needed post-operatively
5. Index procedures requiring total circulatory arrest (TCA), such as aortic arch replacement, planned durable LVAD, durable RVAD, planned right-sided temporary mechanical support of any kind, total artificial heart (TAH), cardiac transplantation, pericardiectomy, pulmonary thromboendarterectomy and septal myectomy
6. Restrictive or obstructive cardiomyopathy, constrictive pericarditis, restrictive pericarditis, pericardial tamponade or other conditions in which cardiac output is dependent on venous return
7. Ventricular septal defect (VSD)
8. Stroke within 30 days of the index cardiac surgical procedure
9. Prior mantle field chest irradiation
10. Prior solid organ or hematologic transplantation (heart, kidney, liver, lung, pancreas, bone marrow) or durable LVAD
11. Pre-existing liver dysfunction defined as: Child-Pugh Class B or C
12. Pre-existing pulmonary disease requiring home oxygen or "severe pulmonary disease" determined by enrolling Investigator
13. Systemic active infection or evidence of systemic bacterial, fungal or viral infection within 72 hours before surgery (blood culture positive with leukocytosis)
14. Confirmed COVID-19 infection within two weeks prior to operation
15. Suspected or known pregnancy
16. Participation in the active treatment or follow-up phase of another interventional clinical trial of an investigational drug or device which has not reached its primary endpoint
17. Known contraindication to heparin; History of bleeding diathesis or known coagulopathy or will refuse blood transfusions
18. Inability to perform aortic cross-clamp, such as due to porcelain aorta
19. Any contraindication or inability to place Impella 5.5 (per the IFU), including LV thrombus and/or presence of a mechanical aortic valve
20. Any organ condition, concomitant disease (e.g., psychiatric illness, current severe alcoholism or current drug abuse, cancer, hepatic or kidney disease), with life expectancy 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 the Investigator and/or Sponsor's Medical Monitor, would pose an unacceptable risk to the subject in the Trial.
21. Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with trial procedures
22. Subject belongs to a vulnerable population [Vulnerable Patient Populations are defined as individuals with mental disability, persons in nursing homes, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention]