PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm

Exclusion Criteria38

• Any prior coronary revascularization or revascularization attempt within 30 days prior to index procedure
• 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
• 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
• Cardiac arrest within 7 days prior to index procedure requiring CPR or defibrillation
• Subjects with sustained ventricular tachycardia or repetitive/ prolonged non-sustained ventricular tachycardia or complex ventricular ectopy
• Current left ventricular thrombus
• Significant right heart failure (right ventricular fractional area change <35% on echocardiography)
• Known severe pulmonary hypertension (right ventricular systolic pressure (RVSP) on echo or pulmonary artery systolic pressure (PASP) on right heart catheterization > 70mmHg
• Combined cardiorespiratory failure
• Presence of an atrial or ventricular septal defect (including post-infarct VSD)
• Hypertrophic obstructive cardiomyopathy (HOCM), restrictive cardiomyopathy, or constrictive pericarditis
• Cardiogenic shock (Cardiac index < 1.8 L/min/m2)
• 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.
• Any use of mechanical circulatory support or an extracorporeal membrane oxygenation device within 14 days prior to index procedure
• Severe aortic valve insufficiency or stenosis or aortic valve replacement
• Clinically-relevant vascular disease that precludes the placement of a MCS device
• Cerebrovascular Accident (CVA) within 180 days prior to index procedure
• Transient Ischemic Attack (TIA) within 90 days prior to index procedure
• 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)
• Known hemoglobin diseases, such as sickle cell anemia, hemolytic anemia or thalassemia
• Subject has evidence of an active infection on the day of the index procedure requiring oral or intravenous antibiotics
• Active infection of the intended access site
• Chronic renal dysfunction (eGFR < 30 mL/min/1.73 m²) and/or patients requiring renal replacement therapy with dialysis
• 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
• Known or suspected severe pulmonary disease (e.g., forced expiratory volume (FEV)1 < 1.0 L/s)
• Allergy, sensitivity or intolerance to anesthesia, heparin, aspirin, adenosine diphosphate (ADP) receptor blockers, or contrast media, including known heparin-induced thrombocytopenia (HIT)
• Any non-cardiac condition with life expectancy < 1 year
• 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.
• Decompensated heart failure requiring IV diuretics, vasopressors or inotropic support within 72 hours of index procedure
• Patients with an organ transplant
• Patients with implanted left ventricular assist device
• Cardiac tamponade
• Left ventricular rupture
• Women who are lactating, pregnant, or plan to become pregnant during the course of the investigation
• Any anatomical restriction that would preclude a MCS device from being delivered through the femoral artery to the left ventricle
• 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
• Current participation in another investigational drug or device trial
• Anticipated need for continued MCS support after conclusion of the PCI procedure