Controlled Arterial Protection to Ultimately Remove Embolic Material

The investigation is a prospective, multi-center, single arm feasibility study. Subjects will undergo treatment with a currently marketed TAVR device and the EmStop Embolic Protection System and will then be followed to 30 days post-procedure. This is a treatment-only feasibility investigation intended to capture and characterize outcomes, especially safety outcomes, with the EmStop System.

Inclusion criteria

Clinical & Angiographic Inclusion Criteria

• Between 21 and 90 years of age at the time of consent
• Meets FDA approved indications for transcatheter aortic valve replacement (TAVR) procedure on a native aortic valve using a commercially available Abbott or Medtronic transcatheter heart valve
• Willing and able to provide written informed consent and written HIPAA authorization prior to initiation of study procedures
• Willing and able to comply with the protocol-specified procedures and assessments
• Subject anatomy is compatible with correct device deployment and positioning with:

• Ability to achieve access with a 21 French equivalent femoral access sheath
• Ascending aorta length ≥8 cm
• Ascending aorta/aortic arch diameter is ≥25 or ≤40 mm
• Ascending aorta or aortic arch exhibits ≤ Grade 1 atheromatous disease and limited wall calcification

Exclusion criteria

• Requires urgent or emergent TAVR procedure
• Contraindicated to MRI
• Previously implanted aortic or mitral valve bioprosthesis
• Hepatic failure (Child-Pugh class C)
• Hypercoagulable state that cannot be corrected by additional periprocedural heparin
• Planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 30 days prior to the TAVR procedure. NOTE: Diagnostic cardiac catheterization is permitted up until baseline MRI is obtained. Once baseline MRI is obtained, no additional intra-aortic or intracardiac procedure may occur.
• Acute myocardial infarction within 30 days of the planned index procedure
• Renal failure, defined as estimated glomerular filtration rate (eGFR) <30 mL/min
• Documented history of stroke or TIA within the prior 6 months, or any prior stroke with a permanent major disability or deficit (NIHSS >1 at baseline)
• Left ventricular ejection fraction ≤30% within 3 months prior to procedure
• History of intolerance, allergic reaction, or contraindication to any of the study medications, including heparin, aspirin, clopidogrel, or a sensitivity to contrast media or anesthesia that cannot be adequately pre-treated
• Known allergy or sensitivity to nickel-titanium
• Active endocarditis or ongoing systemic infection, defined as fever (>38°C) and/or white blood cell (WBC) >15,000 IU
• Undergoing therapeutic thrombolysis
• History of bleeding diathesis or a coagulopathy
• Known or suspected to be pregnant, or is lactating; female subjects of child-bearing potential must have a negative serum or urine pregnancy test within 48 hours prior to the index study procedure.
• Currently participating in another drug or device clinical study
• Any other clinical reason, as deemed by the investigators of the study, by which the patient would not be an appropriate candidate for the study
• Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)