CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material

The objective of this study is to demonstrate safety and efficacy of the EmStop Embolic Protection System when used as indicated to capture and remove thrombus/debris during self-expanding transcatheter aortic valve replacement (TAVR) procedures.

Clinical Inclusion Criteria 1. Age ≥ 22 years at the time of consent 2. Meets FDA-approved indications for elective transfemoral self-expanding transcatheter aortic valve replacement (TAVR) procedure on a native or non-native (valve-in-valve) aortic valve. Note: Due to Neurologist availability and importance of capturing the neurological assessments, procedures must be performed Monday-Thursday. 3. Left ventricular ejection fraction ≥ 30% as confirmed by echocardiogram 4. Willing and able to provide written informed consent and written HIPAA authorization prior to initiation of study procedures 5. Willing and able to comply with the protocol-specified procedures and assessments Imaging Inclusion Criteria 1. Echocardiogram including left ventricular ejection fraction ≥ 30% within 6 months (180 days) prior to the index procedure and prior to randomization to confirm adequate cardiac function. 2. Subjects must undergo a computed tomography angiography (CTA) scan within 6 months (180 days) prior to the index procedure and prior to randomization to confirm anatomic compatibility with the study device and the control device. Subjects must meet the following anatomical inclusion criteria: EmStop Angiographic (CTA) Inclusion Criteria 1. Subject anatomy is compatible with correct device positioning with: * Ascending aorta length ≥8 cm * Femoral and iliac artery minimal lumen diameter of ≥ 8.0 mm * Ascending aorta/aortic arch diameter is ≥25 or ≤40 mm. * Ascending aorta or aortic arch exhibits ≤ Grade 1 atheromatous disease and limited wall calcification Sentinel Angiographic (CTA) Inclusion Criteria 1\. Subject anatomy, excluding bovine arch anatomy, is compatible with correct device positioning with: * Artery diameter is 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery * Arterial stenosis \1 at baseline) 3. Left ventricular ejection fraction \15,000 IU 13. Known allergy to any materials used in the EmStop system (e.g., nitinol) 14. Currently participating in another drug or device clinical study 15. Known or suspected to be pregnant, or is lactating; women of child bearing age must have a negative serum or urine pregnancy test within 48 hours prior to the index study procedure 16. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults) 17. Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study