PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm

Exclusion Criteria

• •1. Any prior coronary revascularization or revascularization attempt within 30 days prior to index procedure
• •2. STEMI within 7 days prior to index procedure - defined as new ST elevation at the J point in at least 2 contiguous leads of ≥ 2 mm (0.2 mV) in men or ≥ 1.5 mm (0.15 mV) in women in leads V2-V3 and/or of ≥ 1 mm (0.1 mV) in other contiguous chest leads or the limb leads
• •3. Non-STEMI within 7 days prior to index procedure with an elevated cardiac biomarker (CK-MB or Troponin \>1x ULN) without CK-MB or Troponin value down trending
• •4. Cardiac arrest within 7 days prior to index procedure requiring CPR or defibrillation
• •5. Subjects with sustained ventricular tachycardia or repetitive/ prolonged non-sustained ventricular tachycardia or complex ventricular ectopy
• •6. Current left ventricular thrombus
• •7. Significant right heart failure (right ventricular fractional area change \<35% on echocardiography)
• •8. Known severe pulmonary hypertension (right ventricular systolic pressure (RVSP) on echo or pulmonary artery systolic pressure (PASP) on right heart catheterization \> 70mmHg
• •9. Combined cardiorespiratory failure
• •10. Presence of an atrial or ventricular septal defect (including post-infarct VSD)
• •11. Hypertrophic obstructive cardiomyopathy (HOCM), restrictive cardiomyopathy, or constrictive pericarditis
• •12. Cardiogenic shock (Cardiac index \< 1.8 L/min/m2)
• •13. Use of inotropic or pressor therapy within 72 hours of the planned index procedure. NOTE: Use of inotropic or pressor therapy for the sole purpose of blood pressure support associated with anesthesia for the procedure is acceptable.
• •14. Any use of mechanical circulatory support or an extracorporeal membrane oxygenation device within 14 days prior to index procedure
• •15. Severe aortic valve insufficiency or stenosis or aortic valve replacement
• •16. Clinically-relevant vascular disease that precludes the placement of a MCS device
• •17. Cerebrovascular Accident (CVA) within 180 days prior to index procedure
• •18. Transient Ischemic Attack (TIA) within 90 days prior to index procedure
• •19. Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000 or spontaneous INR ≥ 1.5 or known fibrinogen ≤ 1.5 g/L)
• •20. Known hemoglobin diseases, such as sickle cell anemia, hemolytic anemia or thalassemia
• •21. Subject has evidence of an active infection on the day of the index procedure requiring oral or intravenous antibiotics
• •22. Active infection of the intended access site
• •23. Chronic renal dysfunction (eGFR \< 30 mL/min/1.73 m²) and/or patients requiring renal replacement therapy with dialysis
• •24. KnownHistory of liver dysfunction with elevation of liver enzymes and bilirubin 3 times the upper limit of normal (ULN) within 90 days prior to index procedure
• •25. Known or suspected severe pulmonary disease (e.g., forced expiratory volume (FEV)1 \< 1.0 L/s)
• •26. Allergy, sensitivity or intolerance to anesthesia, heparin, aspirin, adenosine diphosphate (ADP) receptor blockers, or contrast media, including known heparin-induced thrombocytopenia (HIT)
• •27. Any non-cardiac condition with life expectancy \< 1 year
• •28. Subject is presently or recently intubated for the current admission (NOTE: recently intubated patients must be extubated for \> 24 hours with full neurologic recovery). Procedure-related intubation is acceptable.
• •29. Decompensated heart failure requiring IV diuretics, vasopressors or inotropic support within 72 hours of index procedure
• •30. Patients with an organ transplant
• •31. Patients with implanted left ventricular assist device
• •32. Cardiac tamponade
• •33. Left ventricular rupture
• •34. Women who are lactating, pregnant, or plan to become pregnant during the course of the investigation
• •35. Any anatomical restriction that would preclude a MCS device from being delivered through the femoral artery to the left ventricle
• •36. 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
• •37. Current participation in another investigational drug or device trial
• •38. Anticipated need for continued MCS support after conclusion of the PCI procedure