Cerebral Protection in Transcatheter Aortic Valve Replacement

Exclusion Criteria

• •General
• •1. Vasculature in the right extremity precluding 6Fr sheath radial or brachial access
• •2. Inadequate circulation to the right extremity as evidenced by signs of artery occlusion (modified Allen's test) or absence of radial/brachial pulse
• •3. Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature
• •4. Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment
• •5. Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified
• •6. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+)
• •7. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease)
• •8. Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency
• •9. Blood dyscrasias as defined: Leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy
• •10. Hemodynamic instability requiring inotropic support or mechanical heart assistance.
• •11. Need for emergency surgery for any reason
• •12. Hypertrophic cardiomyopathy with or without obstruction
• •13. Severe ventricular dysfunction with LVEF ≤20%
• •14. Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation
• •15. Symptomatic or asymptomatic severe occlusive carotid disease requiring concomitant CEA/stenting
• •16. Subject has undergone carotid stenting or carotid endarterectomy within the previous 6 weeks
• •17. Active peptic ulcer or upper GI bleeding within the prior 3 months
• •18. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, or clopidogrel, or sensitivity to contrast media, which cannot be adequately pre-medicated
• •19. Recent (within 6 months) CVA or a TIA
• •20. Renal insufficiency (creatinine \> 3.0 mg/dL or GFR \< 30) and/or renal replacement therapy at the time of screening
• •21. Life expectancy \< 12 months due to non-cardiac co-morbid conditions
• •22. Subjects in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion
• •23. Subjects who have active bacterial endocarditis or other active infections
• •24. Currently participating in an investigational drug or another device study
• •25. Subjects who have a planned treatment with any other investigational device or procedure during the study follow-up period (90 days)
• •26. Subject with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation during the study follow-up period (90 days)
• •27. Any subject with a balloon valvuloplasty (BAV) within 30 days of the procedure
• •Neurologic
• •28. Subject had active major psychiatric disease
• •29. Subject has severe visual, auditory, or learning impairment and who are unable to comprehend English and therefore unable to be consented for the study
• •30. Subjects with neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities
• •Angiographic
• •31. Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel System access and insertion
• •32. Subject whose brachiocephalic or left carotid artery reveals significant stenosis, calcification, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium
• •Magnetic Resonance Imaging
• •33. Subject Body Mass Index (BMI) precluding imaging in scanner
• •34. Contraindications to MRI (subjects with any implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure)
• •35. Planned implantation of a pacemaker or defibrillator implantation after TAVR
• •36. Claustrophobia
• •37. Known allergy to gadolinium or contrast agent