Protect the Head to Head Study

Prospective, randomized, open label, multicenter, 2-arm, safety and efficacy study

Inclusion Criteria:Eligible for treatment for symptomatic severe aortic stenosis using a FDA-approved TAVR valve according to current guidelinesConsented to the TAVR procedureSubject and physician agree that subject will return for required post-procedure follow-upWilling to participate in study and provide signed EC/IRB-approved informed consentEighteen (18) years or older at the time of consentExclusion Criteria:Not undergoing a planned TAVR via transfemoral accessSevere allergy or hypersensitivity to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, nitinol, and/or contrast agents that cannot be pre-medicatedUncorrected bleeding disorderHypercoagulation status that cannot be corrected by additional peri-procedural heparinMyocardial infarction (MI) diagnosis <30 days prior to study procedureHistory of substance abuse that may cause non-compliance with the protocol or confound the data interpretationCardiogenic shock, hemodynamic instability requiring inotropic support or mechanical heart assistance, or severe hypotension (systolic blood pressure <90 mmHg) at time of screeningHistory of a stroke < 180 days prior to study procedureActive peptic ulcer or history of upper gastrointestinal (GI) bleeding < 90 days prior to study procedureCongenital unicuspid aortic valvePorcelain aorta, asymmetrical or sharp aortic calcifications, severe aortic tortuosity, shaggy aorta or mobile atheroma in the archPre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiencyCurrent leukopenia, acute anemia, thrombocytopenia, history of chronic bleeding diathesis, or coagulopathy that requires treatmentHypertrophic cardiomyopathy with or without obstructionLeft ventricular ejection fraction (LVEF) ≤20%Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetationActive infection or endocarditisNeurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaultsCarotid stent placement or endarterectomy performed <180 days prior to study procedure.Severe renal insufficiency (creatinine >3.0 mg/dL or GFR <30 mL/min) or patient on dialysisPlanned treatment with another investigational device or procedure during the study periodBalloon valvuloplasty (BAV) within 30 days of the procedureAny 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 procedureEmergency surgery for any reasonPregnancy, lactation or intent to become pregnant during study participationUnable 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 impairmentInvestigator considers participation in the study not to be in the subject's best interestDementia or any other cognitive deficit that results in inability to provide informed consent or comply with the study protocolPresence of hemodialysis shunt, graft, or arterio-venous fistula involving access vasculature