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Completed
NCT07627984
Cerebral Embolic Protection Device During TAVR
Conditions: Cerebral Embolicprotection Device, TAVR
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 260
Sponsor: Shanghai Shenqi Medical Technology Co., Ltd
Location: Xiamen Cardiovascular Hospital Xiamen University Xiamen
Summary
To evaluate the safety and effectiveness of the Cerebral Protection System (model CEP016F, Shanghai Shenqi Medical Technology Co., Ltd.) for capturing and removing thrombotic and tissue debris during transcatheter aortic valve replacement (TAVR).
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07627984). StuddyBuddy aggregates publicly available trial information.
