Protect the Head to Head Study

Eligibility Criteria

• 1. Eligible for treatment for symptomatic severe aortic stenosis using a FDA-approved TAVR valve according to current guidelines
• 2. Consented to the TAVR procedure
• 3. Subject and physician agree that subject will return for required post-procedure follow-up
• 4. Willing to participate in study and provide signed EC/IRB-approved informed consent
• 5. Eighteen (18) years or older at the time of consent
• 1. Not undergoing a planned TAVR via transfemoral access
• 2. Severe allergy or hypersensitivity to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, nitinol, and/or contrast agents that cannot be pre-medicated
• 3. Uncorrected bleeding disorder
• 4. Hypercoagulation status that cannot be corrected by additional peri-procedural heparin
• 5. Myocardial infarction (MI) diagnosis \<30 days prior to study procedure
• 6. History of substance abuse that may cause non-compliance with the protocol or confound the data interpretation
• 7. Cardiogenic shock, hemodynamic instability requiring inotropic support or mechanical heart assistance, or severe hypotension (systolic blood pressure \<90 mmHg) at time of screening
• 8. History of a stroke \< 180 days prior to study procedure
• 9. Active peptic ulcer or history of upper gastrointestinal (GI) bleeding \< 90 days prior to study procedure
• 10. Congenital unicuspid aortic valve
• 11. Porcelain aorta, asymmetrical or sharp aortic calcifications, severe aortic tortuosity, shaggy aorta or mobile atheroma in the arch
• 12. Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency
• 13. Current leukopenia, acute anemia, thrombocytopenia, history of chronic bleeding diathesis, or coagulopathy that requires treatment
• 14. Hypertrophic cardiomyopathy with or without obstruction
• 15. Left ventricular ejection fraction (LVEF) ≤20%
• 16. Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation
• 17. Active infection or endocarditis
• 18. Neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults
• 19. Carotid stent placement or endarterectomy performed \<180 days prior to study procedure.
• 20. Severe renal insufficiency (creatinine \>3.0 mg/dL or GFR \<30 mL/min) or patient on dialysis
• 21. Planned treatment with another investigational device or procedure during the study period
• 22. Balloon valvuloplasty (BAV) within 30 days of the procedure
• 23. Any planned surgical or interventional cardiac procedure (e.g., concurrent coronary revascularization or AF ablation) during the TAVR procedure, within 30 days before or after the TAVR procedure
• 24. Emergency surgery for any reason
• 25. Pregnancy, lactation or intent to become pregnant during study participation
• 26. Unable or unwilling to complete all required screening and/or follow-up assessments, including subjects with active major psychiatric disease; with severe visual, auditory, or learning impairment
• 27. Investigator considers participation in the study not to be in the subject's best interest
• 28. Dementia or any other cognitive deficit that results in inability to provide informed consent or comply with the study protocol
• 29. Presence of hemodialysis shunt, graft, or arterio-venous fistula involving access vasculature