Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR

Eligibility Criteria

• 1. Subject is between 18 and 90 years of age.
• 2. Subject meets FDA approved indications for TAVR procedure on a native aortic valve using an iliofemoral approach with a commercially approved transcatheter heart valve.
• 3. Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 48 hours prior to the index study procedure.
• 4. Subject agrees to comply with all protocol-specified procedures and assessments.
• 5. Subject or subject's legal representative signs an IRB approved informed consent form prior to study participation.
• 1. Subjects with a previously implanted aortic or mitral valve bioprosthesis
• 2. Subjects with hepatic failure (Child-Pugh class C).
• 3. Subjects with hypercoagulable states that cannot be corrected by additional periprocedural heparin.
• 4. Subjects who have a planned treatment with any other investigational device or procedure during the study period.
• 5. Subjects planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 10 days prior to the TAVR procedure. NOTE: Diagnostic cardiac catheterization is permitted within 10 days prior to the TAVR procedure.
• 6. Subject has experienced an acute myocardial infarction (World Health Organization \[WHO\] criteria) within 30 days of the planned index procedure.
• 7. Subject requires an urgent or emergent TAVR procedure.
• 8. Subjects with renal failure (estimated Glomerular Filtration Rate \[eGFR\] \< 30 mL/min by the Modification of Diet in Renal Disease \[MDRD\] formula).
• 9. Subject has documented history of stroke or transient ischemic attack within prior 6 months, or any prior stroke with a permanent major disability or deficit.
• 10. Subject has an ejection fraction of 30% or less.
• 11. Subject has a sensitivity to contrast media that cannot be adequately pre-treated.
• 12. Subject has known allergy or hypersensitivity to any embolic protection device materials (e.g., nickel-titanium) or allergy to intravascular contrast agents that cannot be pre-medicated
• 13. Subject has active endocarditis or an ongoing systemic infection defined as fever with temperature \> 38°C and/ or white blood cell \> 15,000 IU.
• 14. Subjects undergoing therapeutic thrombolysis.
• 15. Subject has history of bleeding diathesis or a coagulopathy or contraindications to anticoagulation and antiplatelet therapy.
• 16. Subject is known or suspected to be pregnant, or is lactating.
• 17. Subject is currently participating in another drug or device clinical study, or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation.