Clinical Research Trials

Key Trial Criteria

• Key Inclusion Criteria

  For a patient to be eligible for participation in this study, all of the following criteria must apply.

  • Symptoms of acute myocardial infarction (AMI) with ECG and/or biomarker evidence of S-T elevation myocardial infarction (STEMI) or non-S-T elevation myocardial infarction (NSTEMI)
  • Cardiogenic shock is defined as the presence of at least two of the following:

  1. Hypotension (systolic blood pressure ≤90 mm Hg, or inotropes/vasopressors to maintain systolic blood pressure ≥90 mmHg)
  2. Signs of end organ hypoperfusion (cool extremities, oliguria or anuria, or elevated lactate levels)
  3. Hemodynamic criteria represented by a cardiac index of <2.2 L/min/m2 or a cardiac power output ≤0.6 watts.

  • Patient is supported with an Impella
  • Patient undergoes PCI

• Key Exclusion Criteria

  A patient will not be eligible for participation in this study if any of the following criteria apply.

  • Evidence of Anoxic Brain Injury
  • Unwitnessed out of hospital cardiac arrest or any cardiac arrest in which return of spontaneous circulation (ROSC) is not achieved within 30 minutes
  • IABP placed prior to Impella
  • Septic, anaphylactic, hemorrhagic, and neurologic causes of shock
  • Non-ischemic causes of shock/hypotension (pulmonary embolism, pneumothorax, myocarditis, tamponade, etc.)
  • Active bleeding for which mechanical circulatory support is contraindicated
  • Recent major surgery for which mechanical circulatory support is contraindicated
  • Mechanical complications of AMI (acute ventricular septal defect (VSD) or acute papillary muscle rupture)
  • Known left ventricular thrombus for which mechanical circulatory support is contraindicated
  • Mechanical aortic prosthetic valve
  • Contraindication to intravenous systemic anticoagulation