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COMPLETED
NCT07627984
NA

Cerebral Embolic Protection Device During TAVR

Sponsor: Shanghai Shenqi Medical Technology Co., Ltd

View on ClinicalTrials.gov

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

Interventions

DEVICE

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