Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR

Other criteria

• Clinical Eligibility Criteria:
• Clinical Inclusion Criteria:
• Subjects must meet ALL the following criteria to be eligible for participation in the study:
• Subject is between 18 and 90 years of age
• Subject meets FDA approved indications for TAVR procedure on a native aortic valve using an iliofemoral approach with a commercially approved transcatheter heart valve
• Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 48 hours prior to the index study procedure
• Subject agrees to comply with all protocol-specified procedures and assessments
• Subject or subject's legal representative signs an IRB approved informed consent form prior to study participation; Clinical Exclusion Criteria:; Subjects will be excluded if ANY of the following criteria apply:
• Subjects with a previously implanted aortic or mitral valve bioprosthesis
• Subjects with hepatic failure (Child-Pugh class C)
• Subjects with hypercoagulable states that cannot be corrected by additional periprocedural heparin
• Subjects who have a planned treatment with any other investigational device or procedure during the study period
• 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
• Subject has experienced an acute myocardial infarction (World Health Organization [WHO] criteria) within 30 days of the planned index procedure
• Subject requires an urgent or emergent TAVR procedure
• Subjects with renal failure (estimated Glomerular Filtration Rate [eGFR] < 30 mL/min by the Modification of Diet in Renal Disease [MDRD] formula)
• 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
• Subject has an ejection fraction of 30% or less
• Subject has a sensitivity to contrast media that cannot be adequately pre-treated
• 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
• Subject has active endocarditis or an ongoing systemic infection defined as fever with temperature > 38°C and/ or white blood cell > 15,000 IU
• Subjects undergoing therapeutic thrombolysis
• Subject has history of bleeding diathesis or a coagulopathy or contraindications to anticoagulation and antiplatelet therapy
• Subject is known or suspected to be pregnant, or is lactating
• 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; Anatomic Eligibility Criteria:; General Anatomic Exclusion Criteria:; Subjects meeting any of the following criteria will not be eligible for participation in the study:
• Non-iliofemoral approach for is required for the TAVR system (e.g., trans-axillary, trans-subclavian, trans-brachiocephalic, trans-carotid, trans-apical or trans-aortic access for TAVR is required)
• Subject peripheral anatomy is not compatible with contralateral iliofemoral access with an 11 French catheter (e.g., due to excessive tortuosity, stenosis, ectasia, dissection, or aneurysm)
• Ascending aorta length (from the site of filter placement to the aortic root) less than 7.5 cm
• Diameter of the aorta at the intended site of Emblok filter deployment proximal to the brachiocephalic artery ostium is less than 25 mm or greater than 40 mm
• Subjects with severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery sheath vascular access
• Subjects in whom the aortic arch is heavily calcified, severely atheromatous, or severely tortuous; Additional Anatomic Exclusion Criteria:; Subjects with any of the following criteria will be excluded from participation in the Randomized Cohort, but are eligible for participation in the Roll-In and Nested Registry cohorts (provided they meet all other eligibility criteria):
• Diameters of the arteries at the site of filter placement are < 9 or > 15 mm for the brachiocephalic artery or < 6.5 or >10 mm in the left common carotid
• Brachiocephalic or carotid vessel with excessive tortuosity
• Compromised blood flow to the right upper extremity, or other conditions that would preclude 6 Fr radial or brachial vascular access (e.g., excessive tortuosity)
• Arterial stenosis >70% in either the left common carotid artery or the brachiocephalic artery
• Brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium