Testing a brain protection device during heart valve replacement to prevent stroke
Studies a brain filter device during TAVR in adults with severe aortic stenosis.
Plain-language title generated from the registry record
Registry title: A Clinical Study on the Use of the Sentinel Cerebral Protection Device During TAVR for the Prevention of Procedure-Related Stroke
Key facts
- Where
- Beijing, ChinaSee the site
Where in China
- Fuwai HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- China National Center for Cardiovascular Diseases
- Trial code
- NCT07045233
- Record updated
- 8 July 2025
- Original description
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.Read full original descriptionShow less
A Clinical Study on the Use of the Sentinel Cerebral Protection Device During TAVR for the Prevention of Procedure-Related Stroke
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.
Inclusion: Patients who meet the surgical indications for Transcatheter Aortic Valve Replacement (TAVR), diagnosed as symptomatic severe aortic stenosis, receive a Sentinel Cerebral Protection System during the procedure, and are adult patients who have been informed and consented to participate in this study.
Exclusion: History of cerebral disease within 1 year prior to the procedure (e.g., stroke, cerebral hemorrhage, brain tumor, encephalitis, traumatic brain injury, or other craniocerebral-related diseases); History of previous open-chest surgery or previous heart valve replacement. Patients with left ventricular ejection fraction ≤ 30%. Presence of contraindications for MRI examination. Patients with claustrophobia. Patients unable to comply with follow-up.