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

Exclusion Criteria

• •1. Requires use of a balloon-expandable transcatheter aortic valve for the index procedure
• •2. Documented history of stroke or transient ischemic attack (TIA) within the prior 6 months, or any prior stroke with a permanent major disability or deficit (National Institute of Health Stroke Scale \[NIHSS\] \>1 at baseline)
• •3. Left ventricular ejection fraction \<30%, cardiogenic shock, or hypotension requiring inotropes or mechanical circulatory support, within 3 months prior to index procedure
• •4. Acute myocardial infarction (MI) within 30 days of the planned index procedure
• •5. Planned to undergo any other open cardiac surgical or left heart interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 30 days prior to the TAVR procedure. The need for a postoperative pacemaker implant after TAVR is not exclusionary.
• •6. Renal failure, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min
• •7. Hypercoagulable state that cannot be corrected by additional periprocedural heparin
• •8. 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
• •9. Undergoing therapeutic thrombolysis
• •10. History of bleeding diathesis or major coagulopathy
• •11. Hepatic failure (Child-Pugh class C)
• •12. Active endocarditis or ongoing systemic infection, defined as fever (\>38°C) and/or WBC \>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