A Clinical Study on the Use of the Sentinel Cerebral Protection Device During TAVR for the Prevention of Procedure-Related Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sentinel® Cerebral Protection System, MRI.
- Who it may be relevant to
- Registry conditions: Stroke, Transcatheter Aortic Valve Replacement (TAVR), Aortic Stenosis Treated With TAVI. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First) [Time frame: From enrollment to 72 hours post surgery or discharge (whichever comes first)]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fuwai Hospital — Beijing
Identifiers
NCT: NCT07045233 · 2024-KJCX04-04