Feasibility Study of the transShield Embolic Protection System

1. Patient is ≥18 years old
2. Patient is scheduled for percutaneous TAVR using a commercial TAVR system
3. Patient meets indications for TAVR per the device IFU
4. The diameter of the artery at the site of the filter placement is ≤ 42 mm
5. Size and condition of the femoral artery iliac arteries are appropriate for the 10F transShield Introducer
6. Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated procedures
7. Patient is willing and able to complete follow-up requirement

Exclusion Criteria:

1. Patient not undergoing TAVR via the trans-femoral route
2. Carotid artery stenosis > 70% in either carotid artery
3. Severe vascular tortuosity or anatomy that would preclude the safe introduction of the device
4. Aortic valve is a congenital unicuspid valve or is non-calcified
5. Predominant aortic regurgitation >3+
6. A known contraindication or hypersensitivity to all anticoagulation regimens or an inability to undergo anticoagulation for the study procedure
7. History of bleeding diathesis or in whom anticoagulant and/or anti- platelet therapy is contraindicated, patients who will refuse transfusion, or have an active peptic ulcer or upper GI bleeding within the prior 3 months
8. Renal disease requiring chronic dialysis at time of treatment
9. History of stroke or transient ischemic attack (TIA) within prior 6 months
10. Evidence of an acute myocardial infarction (MI) within 30 days prior to study procedure
11. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within prior 30 days
12. Severe left ventricular (LV) dysfunction with LV ejection fraction (LVEF) \<20%
13. Severe pulmonary hypertension and right ventricular (RV) dysfunction
14. Echocardiographic evidence of intracardiac mass, thrombus or vegetation
15. Life expectancy \<12 months due to non-cardiac co-morbid conditions
16. Evidence of active systemic or local groin infection
17. Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma or severe atheroma (especially with calcification and surface irregularities) of the thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta
18. Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, ticlopidine, or clopidogrel, and/or contrast agents, that cannot be managed with premedication

19. Planned other cardiac surgical procedure within 2 weeks prior to or planned cardiac surgical or interventional procedure within 30 days after the TAVR procedure.

    Note: Diagnostic cardiac catheterization is permitted within 10 days prior to the TAVR procedure

20. Known allergy to any device component
21. Known or suspected to be pregnant or lactating
22. Currently enrolled in an investigational drug or device clinical study in which the primary endpoint has not occurred
23. Patient has other medical, social or psychological problem that in the opinion of the investigator precludes them from participating