The RECOVER IV Trial

Inclusion Criteria:

1. Cardiogenic shock with onset ≤12 hours after STEMI and prior to index PCI, asdefined by having both the following:

2. Persistent SBP <90 mmHg for ≥30 minutes despite fluid resuscitation orpressors/inotropes required to maintain SBP ≥90 mmHg and

3. Signs of impaired organ perfusion (cool extremities and/or altered mentalstatus)

4. One of the following must be present on a standard 12-lead electrocardiogram (ECG):

5. ST-segment elevation (≥2 mm elevation of ST-segments in ≥2 contiguous leadswithout left bundle branch block) or

6. Anterior (V1-V4) ST-segment depression ≥2 mm in ≥2 contiguous leads consistentwith a possible posterior infarction AND coronary angiogram prior torandomization showing acute total or subtotal occlusion of the proximalcircumflex artery or

7. aVR ST-segment elevation ≥2 mm without anterior ST-segment elevation ANDcoronary angiogram prior to randomization confirming left main culprit lesion

• NOTE: Patients with isolated RV infarction are excluded from thisProtocol. If a patient qualifies with cardiogenic shock with only inferiorST-segment elevation, pre-randomization assessment of LV function must beobtained with either point of care echocardiography or contrast leftventriculography to demonstrate a LVEF ≤40% for the patient to be eligiblefor randomization.

3. Intended emergent PCI to treat the STEMI

4. Subject is able to and agrees to provide written informed consent. If the subject isunable to be consented because of their extreme illness and a legally authorizedrepresentative (LAR) is present, the LAR must agree and provide written informedconsent. If the subject is unable to provide consent because of their extremeillness and an LAR is not present, the patient may be randomized under Exceptionfrom Informed Consent (EFIC) Guidance

Exclusion Criteria:

1. High suspicion for isolated right ventricular infarct confirmed with ECG lead V4R

2. Cardiogenic shock with either of the following:

3. High-grade atrioventricular block (heart rate (HR) <50 bpm)

• NOTE: If patient is paced, via temporary or permanent pacemaker, and stillin shock, they are still eligible

2. Isolated narrow complex supraventricular tachycardia with ventricular response >170 bpm or ventricular tachyarrhythmia with ventricular response >150 bpm

3. Known mechanical complications of acute myocardial infarction (AMI) that may causecardiogenic shock such as free wall rupture, cardiac tamponade, ventricular septaldefect or papillary muscle rupture with acute mitral regurgitation

4. Left ventricular function (LVEF >40%) on echocardiography or LV-gram (if performed)indicating shock due to another cause (e.g., RV infarction as the principal cause ofshock, hypovolemia, sepsis or high cardiac output shock)

5. Severe bilateral peripheral arterial disease precluding femoral Impella CP insertion (femoral angiogram required) NOTE: Impella insertion via a non-femoral arterialroute is not permitted in this Protocol.

6. IABP, Impella or other mechanical circulatory support already in place for presentindication (pre-randomization)

7. Known end-stage renal disease, receiving dialysis

8. Severe aortic stenosis, or moderate or worse aortic regurgitation or priorself-expanding transcatheter aortic valve replacement (TAVR), or surgically placedmechanical valve, if known

9. Acute or chronic aortic dissection, if known

10. Large or mobile LV thrombus, if known

11. Prior PCI for the present infarction

12. Prior PCI or coronary artery bypass graft (CABG) within 1 year, if known

13. Ongoing cardiopulmonary resuscitation (CPR)

14. Not obeying verbal commands after preadmission or in-hospital cardiac arrest

• NOTE: (i) A positive and appropriate response to commands must be repeatable onat least two (2) instances to rule out reflex response to voice (ii) Intubatedsubjects may be enrolled if:

1. They did not have a cardiac arrest and were following verbal commandsprior to intubation or

2. They are clearly following verbal commands after intubation

3. Prior stroke with permanent, significant neurological defect

4. Prior intracranial hemorrhage or known intracerebral mass, aneurysm or fistula

5. Acute or suspected stroke prior to randomization

6. Active infection requiring oral or intravenous antibiotics

7. Prior heparin-induced thrombocytopenia, if known

8. Other severe, concomitant disease with limited life expectancy <1 year (other thancardiogenic shock)

9. Pregnancy, known or suspected

10. 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 orany cardiogenic shock trial other than a registry

11. If known, subject has previously been symptomatic with or hospitalized for COVID-19unless he/she has been discharged (if hospitalized) and asymptomatic for ≥4 weeksand has returned to his/her prior baseline (pre-COVID) clinical condition

12. Subject has other medical, social or psychological conditions that, in the opinionof the Investigator, compromises the subject's ability to comply with studyprocedures (e.g., dementia, severe alcohol or substance abuse)

13. Patient belongs to a vulnerable population [Vulnerable patient populations mayinclude individuals with mental disability, persons in nursing homes, impoverishedpersons, homeless persons, nomads, refugees and those permanently incapable ofgiving informed consent. Vulnerable populations also may include members of a groupwith a hierarchical structure such as university students, subordinate hospital andlaboratory personnel, employees of the Sponsor, members of the armed forces andpersons kept in detention]

14. Patient is wearing a bracelet or other item indicating their wishes to declineparticipation in the study