NCT07045233

A Clinical Study on the Use of the Sentinel Cerebral Protection Device During TAVR for the Prevention of Procedure-Related Stroke

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

After more than a decade of development, transcatheter aortic valve replacement (TAVR) is now a standard, guideline-recommended treatment for all symptomatic patients with severe aortic stenosis, regardless of their surgical risk. However, stroke remains a risk for these patients after TAVR. Given its severe impact-significantly increasing post-procedure mortality and severely affecting quality of life-preventing TAVR-related stroke is an urgent problem we need to solve. The Sentinel Cerebral Protection Device is a percutaneous dual-filter brain protection system. During the procedure, the Sentinel device's filters capture blood clots and tissue debris. After the operation, the captured clots and debris are removed from the body along with the device. Its safety and effectiveness have been validated. Therefore, this project plans to conduct a multi-center registry clinical study to: Develop a widespread neurological risk prediction model. Create a strict, standardized prevention protocol. Boost awareness of perioperative stroke prevention during TAVR. Provide practical clinical experience. By doing so, we aim to better prevent strokes in patients undergoing TAVR.

Conditions

• Stroke
• Transcatheter Aortic Valve Replacement (TAVR)
• Aortic Stenosis Treated With TAVI

Interventions

Type	Name	Description
DEVICE	Sentinel® Cerebral Protection System	Deploy a Sentinel cerebral protection device during TAVR for patient with aortic stenosis.
DIAGNOSTIC_TEST	MRI	Patients receive head MRI before and after the surgery in order to determine the stroke incidence.

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-12-01
• Completion: 2028-07-01
• First posted: 2025-07-01
• Last updated: 2025-07-08

Locations

1 site across 1 country: China