Cardiovascular Systems Inc. (CSI) pVAD First in Human Study

CSI Percutaneous Ventricular Assist Device (pVAD) First in Human Study

This study will collect initial clinical data on the CSI pVAD system to inform device design and finalization.

Inclusion Criteria:

1. Male or non- pregnant female ≥ 18 years of age
2. Life expectancy ≥ 1 year
3. Ejection Fraction (EF) >15% and ≤ 40%
4. Scheduled for an elective high risk percutaneous coronary intervention

Exclusion Criteria:

1. Hemodynamically unstable MI with elevated cardiac biomarker and no evidence of at least 1 consecutive CK-MB or troponin value trending downward from a previous value OR ST-Elevation Myocardial Infarction (STEMI) within 14 days of Index Procedure
2. Pre-Procedure cardiac arrest within 24 hours of enrollment requiring cardiopulmonary resuscitation
3. Cardiogenic shock
4. Left ventricular (LV) mural thrombus
5. Presence of a prosthetic valve or a heart constrictive device
6. Aortic stenosis
7. Moderate or severe aortic regurgitation (≥ 2+ by echo)
8. Severe peripheral vascular disease that will preclude the use of a 12F access sheath, which is required for the insertion of the CSI pVAD catheter
9. Severe aortic tortuosity
10. Severe aortic calcification
11. Vasculature will not tolerate a right heart catheterization
12. Renal dysfunction (serum creatinine ≥ 2.5 mg/dl) or requirement for hemodialysis
13. Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3X upper lab normal (ULN) or Internationalized Normalized Ratio (INR) ≥ 2 or lactate dehydrogenase (LDH) > 2.5X ULN
14. Uncorrectable abnormal coagulation parameters
15. History of heparin induced thrombocytopenia
16. Sustained ventricular tachycardia
17. Stroke or transient ischemic attack (TIA) within 6 months or any permanent neurological deficit
18. Chronic anemia (hemoglobin < 8 g/dL)
19. Subject may require long term support with a commercially available hemodynamic support device
20. Active systemic infection requiring oral or intravenous antibiotics
21. Allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or antiplatelet therapy drugs that cannot be adequately premedicated
22. Allergy or intolerance to system components
23. Participation in another investigational drug or device study