Cerebral Embolic Protection Device During TAVR

Inclusion Criteria:

1. Age ≥18 years, male or non-pregnant/non-lactating female.
2. Suitable for TAVR and planned to undergo TAVR using an approved transcatheter aortic valve system.
3. TAVR access limited to transfemoral or transapical approach.
4. Imaging-confirmed left common carotid artery diameter of 6.5-10 mm and brachiocephalic artery diameter of 9-15 mm at the site of filter placement.
5. No severe stenosis (>70%), dilation, dissection, ostial aneurysm, or aneurysm within 3 cm of the aortic origin in the target vessels.
6. Brain imaging evaluable by 3-Tesla magnetic resonance imaging.
7. Willing to comply with protocol-required follow-up assessments.
8. Written informed consent provided by the subject or legal guardian.

Exclusion Criteria:

1. Impaired right upper limb blood flow.
2. Intracranial hemorrhage, stroke, or transient ischemic attack within 6 months before procedure.
3. Acute myocardial infarction within 1 month before procedure.
4. Calcification in the intended filter deployment region.
5. Planned pacemaker or defibrillator implantation within 30 days after TAVR.
6. Left ventricular ejection fraction ≤20%.
7. Infective endocarditis, intracardiac/aortic mass, thrombus, or vegetation on echocardiography.
8. Severe occlusive carotid disease requiring concomitant carotid intervention, or carotid stenting/endarterectomy within 6 weeks.
9. Leukopenia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulation disorder.
10. Active peptic ulcer disease or gastrointestinal bleeding within 3 months.
11. Severe allergy or known contraindication to nitinol, stainless steel alloy, or contrast media.
12. Contraindication to antiplatelet and/or anticoagulation therapy, or refusal of blood transfusion.
13. Severe renal insufficiency (serum creatinine >3.0 mg/dL, eGFR <30 mL/min, or need for renal replacement therapy).
14. Known psychiatric disease or substance abuse that may interfere with compliance or data interpretation.
15. Life expectancy <1 year.
16. Active infection requiring concurrent antibiotic therapy.
17. Other clinical conditions preventing compliance with the instructions for use of the investigational device.
18. Concurrent use or planned use of another investigational device or drug during the study period.
19. Severe tortuosity of right upper extremity vessels or inability to accommodate a 6 F sheath.
20. Contraindication to MRI, including implanted pacemaker/defibrillator, metal implants, metal fragments, clips, or intracranial/ocular implanted devices.