Primary Outcome Measures: | |
1. |
All-Cause Mortality [ Time Frame: 30 Days ]
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Secondary Outcome Measures: | |
1. |
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) [ Time Frame: 30 Days ]
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2. |
Days Alive Out-of-Hospital [ Time Frame: 6 Months ]
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3. |
Mean Change in Health-Related Quality of Life, as measured by Kansas City Cardiomyopathy Questionnaire [ Time Frame: 1 Year ]
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Other Outcome Measures: | |
1. |
All-Cause Mortality [ Time Frame: At hemodynamic stability and when the subject is no longer hospitalized, 6 Months, 1 Year ]
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2. |
MACCE [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized, 6 Months, 1 Year ]
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3. |
Days Alive Out-of-Hospital [ Time Frame: 30 Days, 6 Months ]
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4. |
Mean Change in Health-Related Quality of Life, as measured by Kansas City Cardiomyopathy Questionnaire [ Time Frame: 30 Days Post-Discharge, 6 Months ]
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5. |
Mean Change in Health-Related Quality of Life, as measured by Rose Dyspnea Score [ Time Frame: 30 Days Post-Discharge, 6 Months, 1 Year ]
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6. |
Mean Change in Health-Related Quality of Life, as measured by EQ-5D-5L [ Time Frame: 30 Days Post-Discharge, 6 Months, 1 Year ]
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7. |
Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 30 Days, 6 Months ]
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8. |
Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized, 30 Days, 6 Months, 1 Year ]
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9. |
Number of Participants with need for In-Hospital Hemodialysis or Continuous Renal Replacement Therapy (CRRT) [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized ]
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10. |
Number of Participants with need for Dialysis Post-Index Hospitalization [ Time Frame: 30 Days, 6 Months, 1 Year ]
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11. |
Number of Participants with any Dialysis [ Time Frame: 30 Days, 6 Months, 1 Year ]
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12. |
All-Cause Hospitalizations [ Time Frame: 30 Days, 6 Months, 1 Year ]
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13. |
Cardiovascular Hospitalizations [ Time Frame: 30 Days, 6 Months, 1 Year ]
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14. |
Heart Failure Hospitalizations [ Time Frame: 30 Days, 6 Months, 1 Year ]
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15. |
Number of Participants with new Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) Implant [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized, 30 Days, 6 Months, 1 Year ]
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16. |
Number of Participants with Left Ventricular Assist Device (LVAD) or Heart Transplant (including United Network for Organ Sharing (UNOS) 1/2 listing) [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized, 30 Days, 6 Months, 1 Year ]
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17. |
Repeat Target Vessel Revascularization (TVR) [ Time Frame: 30 Days, 6 Months, 1 Year ]
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18. |
Acute Kidney Injury (AKI) [ Time Frame: within 7 Days Post-Percutaneous Coronary Intervention (PCI) ]
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19. |
Disability Assessed using the Modified Rankin Scale [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized, 30 Days, 6 Months, 1 Year ]
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20. |
30-day survival with mRS score ≤3 [ Time Frame: 30 day ]
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21. |
Number of Participants with Neurologic Academic Research Consortium (NeuroARC) Type 1 Stroke [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized ]
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22. |
Major Bleeding [ Time Frame: Shock Academic Research Consortium (SHARC) Types 3-5, At hemodynamic stability when the subject is no longer hospitalized ]
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23. |
Major Vascular Complications [ Time Frame: SHARC Definition, At hemodynamic stability when the subject is no longer hospitalized ]
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24. |
Major Hemolysis [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized ]
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25. |
Major Cath Lab Complications [ Time Frame: All adverse events will be recorded and documented through 1 year follow up or study completion ]
Intubation; new bradyarrhythmia requiring a temporary pacemaker; ventricular arrhythmias requiring cardioversion or defibrillation; persistent severe hypotension or heart failure requiring escalation beyond the randomized study devices (Impella CP in the Treatment Arm and intra-aortic balloon pump (IABP) in the Control Arm). |
26. |
All Stroke [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized ]
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27. |
Minor Bleeding [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized ]
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28. |
Minor Vascular Complications [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized ]
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29. |
Minor Hemolysis [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized ]
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