Vortex - Temporary Percutaneous, Transvalvular Circulatory Support System Feasibility Study

Inclusion Criteria

A subject will be considered for enrolment in the study if all of the following inclusion criteria are met, provided no exclusion criteria are met:

IC1. Subject provides signed informed consent. IC2. Subject is ≥ 18 years and 15 mmHg -AND-

• Hypotension (systolic blood pressure 30 minutes) -OR-
• Need for supportive measures (i.e., inotropes or mechanical support) to maintain systolic blood pressure ≥ 90 mmHg and end organ hypoperfusion (cool extremities or urine 60 beats per minute) EC4. Subject has left ventricular mural thrombus. EC5. Subject has a prosthetic aortic valve. EC6. Subject has pericarditis or constrictive heart disease (constrictive pericarditis or restrictive cardiomyopathy).

EC7. Subject has moderate or greater aortic valve stenosis or moderate or greater aortic valve insufficiency (by echocardiographic assessment, graded as ≥ 2+).

EC8. Subject has abnormalities of the aorta that preclude safe delivery of the device, including severe calcification, tortuosity, aneurysm, or prior surgery.

EC9. Subject has peripheral vessel disease (PVD) preventing passage of the device (e.g., calcification, small caliber) or tortuosity that would preclude safe placement of the 16 Fr introducer sheath.

Note: Minimum required vessel diameter is > 5.5 mm. EC10. Subject has advanced renal dysfunction (AKIN Stage 3). EC11. Subject has a history of liver dysfunction (Childs Class C) with elevation of liver enzymes and bilirubin > 3× upper limit of normal (ULN) or international normalization ratio (INR) ≥ 2.

EC12. Subject has had a recent (within 1 month) stroke or TIA. EC13. Subject has known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or has known hypersensitivity to heparin, aspirin, ADP receptor inhibitors or nitinol.

EC14. Subject has current or a history of heparin induced thrombocytopenia (HIT).

EC15. Subject has uncorrected abnormal coagulation or platelet count ≤ 75,000/mm³ or INR ≥ 2.0.

EC16. Subject has significant right heart failure (right atrial pressure [RAP] > 15 mmHg, right ventricular stroke work index [RVSWI] 3.6 Woods units).

EC17. Subject requires mechanical ventilation. EC18. Subject has an atrial or ventricular septal defect (including post-infarct ventricular septal defect [VSD]).

EC19. Subject has left ventricular rupture. EC20. Subject has cardiac tamponade. EC21. Subject has severe pulmonary disease (FEV1 < 1L). EC22. Subject has sustained or non-sustained ventricular tachycardia. EC23. Subject is breast feeding or is pregnant.