Pulmonary Artery Catheter in Cardiogenic Shock Trial

Inclusion Criteria:

1. Age ≥18 years and ≤90 years

2. Clinical heart failure presentation and left ventricular function as follows: Either 2A or 2B must be present A. Subject has de novo acute decompensated heart failureand shock with an LVEF ≤40% OR B. Subject has acute on chronic heart failure with adocumented history of a LVEF ≤40% within 6 months of admission and a current LVEF ≤40% within 24 hours of screening during the current hospitalization. NOTE: The LVEF must be quantitatively measured as ≤ 40% by an echocardiogram within 24 hours of screening. If multiple echocardiograms have been performed within 24hours, the most recent test must be used to qualify the patient.

3. Cardiogenic Shock (CS) defined by a lactate level ≥ 2.1 mmol/L and any 2 of thefollowing parameters within 24 hours of screening:

4. SBP <90 mmHg for more than 30 minutes from baseline SBP

5. Requires the use of at least 1 vasopressor or inotrope

6. Requires intra-aortic balloon pump (IABP) support

7. Presence of congestion on exam: JVP elevated, pulmonary edema on CXR or exam,dyspnea at rest, orthopnea, bendopnea, or worsening peripheral or abdominalswelling

8. Initial diagnosis of CS within 24 hours of screening at the enrolling site

9. Patient or legally authorized representative provides informed consent

A HIPAA waiver for screening is requested to identify potential subjects. No recruitment materials will be given to potential subjects. No identifiable data will be retained for subjects that are determined to be ineligible

Exclusion Criteria:

1. Primary etiology of shock other than systolic left heart failure including but notlimited to: acute myocardial infarction, sepsis, hypovolemia, hemorrhage, severeanemia, primary RV failure, pulmonary embolism, or tamponade.

2. Patient has a durable ventricular assist device or temporary mechanical circulatorysupport (other than IABP) or PAC prior to enrollment

3. Actively listed for cardiac transplantation (Status 7 patients are eligible for thetrial)

4. Patient transferred from another facility with a diagnosis of cardiogenic shock

5. Any known co-morbidity other than heart failure with anticipated survival < 6 months

6. Pre-enrollment labs (any of the following): International Normalized Ratio (INR) > 3, Platelet count < 50k, Hemoglobin < 7

7. Refractory or recurrent cardiac arrest (>1 episode requiring defibrillation orcardiopulmonary resuscitation) within 24 hours prior to screening

8. DNR/ DNI status

9. Pregnancy, child-birth within 6 months, or lactation

10. Active infection documented by persistent fever (Temp > 38.4oC within 24 hours ofscreening) or confirmed bacteremia

11. Implantation of PPM or ICD within past 3 months

12. Mechanical complication of AMI (ie VSD, papillary muscle rupture, flail mitralregurgitation, free wall rupture)

13. Anoxic brain injury

14. On renal replacement therapy prior to enrollment

15. Cardiac surgery within 3 months of current admission

16. Severe aortic, pulmonic, tricuspid stenosis or acute structural mitral regurgitationor infective endocarditis

17. History of cardiac amyloid

18. Congenital heart disease excluding the presence of a bicuspid aortic valve

19. Planned cardiac surgery during admission

20. World Health Organization (WHO) Group I, III, IV, or V pulmonary hypertension

21. Any known contraindication to PAC placement

22. Participation in the active treatment or follow-up phase of another clinical studyof an investigational drug or device that has not reached its primary endpoint

23. Any medical or psychiatric condition such as dementia, alcoholism, or substanceabuse which may preclude informed consent or interfere with any of the studyprocedures, including follow-up

24. Prior stroke with any permanent neurologic deficit or any prior intracranialhemorrhage or any prior subdural hematoma or known intracranial pathologypre-disposing to intracranial bleeding, such as an arteriovenous malformation ormass

25. Subject has previously hospitalized for COVID-19 unless he/she has been dischargedand asymptomatic for ≥4 weeks

26. Subject is COVID-19 PCR/antigen positive within the prior 4 weeks

27. Subject belongs to a vulnerable population [defined as individuals with mentaldisability, 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 hierarchicalstructure such as university students, subordinate hospital and laboratorypersonnel, members of the armed forces and persons kept in detention]