Controlled Arterial Protection to Ultimately Remove Embolic Material

Inclusion Criteria:

Clinical & Angiographic Inclusion Criteria

1. Between 21 and 90 years of age at the time of consent

2. Meets FDA approved indications for transcatheter aortic valve replacement (TAVR)procedure on a native aortic valve using a commercially available Abbott orMedtronic transcatheter heart valve

3. Willing and able to provide written informed consent and written HIPAA authorizationprior to initiation of study procedures

4. Willing and able to comply with the protocol-specified procedures and assessments

5. 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 andlimited wall calcification

Exclusion Criteria:

1. Requires urgent or emergent TAVR procedure

2. Contraindicated to MRI

3. Previously implanted aortic or mitral valve bioprosthesis

4. Hepatic failure (Child-Pugh class C)

5. Hypercoagulable state that cannot be corrected by additional periprocedural heparin

6. Planned to undergo any other cardiac surgical or interventional procedure (e.g.,concurrent coronary revascularization) during the TAVR procedure or within 30 daysprior to the TAVR procedure. NOTE: Diagnostic cardiac catheterization is permittedup until baseline MRI is obtained. Once baseline MRI is obtained, no additionalintra-aortic or intracardiac procedure may occur.

7. Acute myocardial infarction within 30 days of the planned index procedure

8. Renal failure, defined as estimated glomerular filtration rate (eGFR) <30 mL/min

9. Documented history of stroke or TIA within the prior 6 months, or any prior strokewith a permanent major disability or deficit (NIHSS >1 at baseline)

10. Left ventricular ejection fraction ≤30% within 3 months prior to procedure

11. History of intolerance, allergic reaction, or contraindication to any of the studymedications, including heparin, aspirin, clopidogrel, or a sensitivity to contrastmedia or anesthesia that cannot be adequately pre-treated

12. Known allergy or sensitivity to nickel-titanium

13. Active endocarditis or ongoing systemic infection, defined as fever (>38°C) and/orwhite blood cell (WBC) >15,000 IU

14. Undergoing therapeutic thrombolysis

15. History of bleeding diathesis or a coagulopathy

16. Known or suspected to be pregnant, or is lactating; female subjects of child-bearingpotential must have a negative serum or urine pregnancy test within 48 hours priorto the index study procedure.

17. Currently participating in another drug or device clinical study

18. Any other clinical reason, as deemed by the investigators of the study, by which thepatient would not be an appropriate candidate for the study

19. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)