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Cerebral Embolic Protection Device During TAVR
Sponsor: Shanghai Shenqi Medical Technology Co., Ltd
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).
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of a Cerebral Embolic Protection Device for Capturing and Removing Thrombus/Tissue Debris During Transcatheter Aortic Valve Replacement
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
260
Start Date
2023-09-20
Completion Date
2025-04-16
Last Updated
2026-06-04
Healthy Volunteers
No
Conditions
Interventions
Cerebral embolic protection device
The cerebral embolic protection device is a percutaneously delivered dual-filter protection device designed to capture and remove dislodged debris during transcatheter aortic valve replacement (TAVR). The system utilizes one filter delivered to the brachiocephalic trunk (proximal filter) and a second filter delivered to the left common carotid artery (distal filter). Upon completion of the procedure, the filters and debris are retrieved back into the catheter and removed from the patient.
Locations (1)
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, China