PICANTE: PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm

Information coming soon.

Sex: ALL
Minimum Age: 18 Years
Maximum Age: 90 Years
Healthy Volunteers: No
Age Groups: ADULT, OLDER_ADULT

Inclusion Criteria:

1. Subject age ≥ 18 and ≤ 90 years at the time of screening
2. The subject has an LV ejection fraction of 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 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 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