Protect the Head to Head Study

Exclusion Criteria

• •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