PROTECT H2H – Protect the Head to Head: A Safety and Efficacy Assessment of the Emboliner Embolic Protection Device

Prospective, randomized, open label, multicenter, 2-arm, safety and efficacy study to demonstrate safety and effectiveness based on non-inferiority of the study device (Emboliner EPD) compared to the control device (Sentinel CPS) in terms of a 30-day composite major adverse cardiac and cerebrovascular events (MACCE) rate - defined as all death, stroke and Stage 3 acute kidney injury - evaluated on a per-patient basis, post-TAVR procedures

Inclusion Criteria:

• Eligible for treatment for symptomatic severe aortic stenosis using a FDA-approved TAVR valve according to current guidelines
• Consented to the TAVR procedureSubject and physician agree that subject will return for required post-procedure follow-up
• Willing to participate in study and provide signed EC/IRB-approved informed consent
• Eighteen (18) years or older at the time of consent

Exclusion Criteria:

• Not undergoing a planned TAVR via transfemoral access
• Severe allergy or hypersensitivity to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, nitinol, and/or contrast agents that cannot be pre-medicated
• Uncorrected bleeding disorder
• Hypercoagulation status that cannot be corrected by additional peri-procedural heparin
• Myocardial infarction (MI) diagnosis <30 days prior to study procedure
• History of substance abuse that may cause non-compliance with the protocol or confound the data interpretation
• Cardiogenic shock, hemodynamic instability requiring inotropic support or mechanical heart assistance, or severe hypotension (systolic blood pressure <90 mmHg) at time of screening
• History of a stroke < 180 days prior to study procedure
• Active peptic ulcer or history of upper gastrointestinal (GI) bleeding < 90 days prior to study procedure
• Congenital unicuspid aortic valve
• Porcelain aorta, asymmetrical or sharp aortic calcifications, severe aortic tortuosity, shaggy aorta or mobile atheroma in the arch
• Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency
• Current leukopenia, acute anemia, thrombocytopenia, history of chronic bleeding diathesis, or coagulopathy that requires treatment
• Hypertrophic cardiomyopathy with or without obstruction
• Left ventricular ejection fraction (LVEF) ≤20%
• Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation
• Active infection or endocarditis
• Neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults
• Carotid 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 dialysis
• Planned treatment with another investigational device or procedure during the study period
• Balloon valvuloplasty (BAV) within 30 days of the procedure
• 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
• Emergency surgery for any reason
• Pregnancy, lactation or intent to become pregnant during study participation
• 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
• Investigator considers participation in the study not to be in the subject's best interest
• Dementia or any other cognitive deficit that results in inability to provide informed consent or comply with the study protocol
• Presence of hemodialysis shunt, graft, or arterio-venous fistula involving access vasculature