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

NCT07045233 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-07-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • China National Center for Cardiovascular Diseases

    lead OTHER_GOV

Principal Investigators

  • Yongquan Xie · Chinese Academy of Medical Sciences, Fuwai Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2027-12-31
Completion
2028-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07045233 on ClinicalTrials.gov