StrokeSENTINEL-TAVRNCT07045233
A Clinical Study on the Use of the Sentinel Cerebral Protection Device During TAVR for the Prevention of Procedure-Related Stroke
An observational study of Stroke and Transcatheter Aortic Valve Replacement (TAVR), run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Transcatheter Aortic Valve Replacement (TAVR), Aortic Stenosis Treated With TAVI
- What is being tested?
- Sentinel® Cerebral Protection System and MRI
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to Jul 2028
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in China
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- Sentinel® Cerebral Protection System, MRI
- Keywords
- stroke, Cerebral Protection Device, TAVR
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel® Cerebral Protection SystemDevice
Deploy a Sentinel cerebral protection device during TAVR for patient with aortic stenosis.
MRIDiagnostic test
Patients receive head MRI before and after the surgery in order to determine the stroke incidence.
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)
All stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) through 72 hours post TAVR procedure or discharge (whichever comes first), as adjudicated by an independent Clinical Events Committee (CEC) and using Neurologic Academic Research Consortium (NeuroARC) definitions.
Measured: From enrollment to 72 hours post surgery or discharge (whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Jun 2025
- Primary completionDec 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yongquan Xie, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045233
- Sponsor's protocol ID
- 2024-KJCX04-04
- Acronym
- SENTINEL-TAVR
- Status last verified
- Aug 2024
- First submitted
- 22 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Use of the Sentinel Cerebral Protection Device During TAVR for the Prevention of Procedure-Related Stroke
- ClinicalTrials.gov ID
- NCT07045233
- Acronym / sponsor ID
- SENTINEL-TAVR / 2024-KJCX04-04
- Keywords
- stroke, Cerebral Protection Device, TAVR
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in China
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel® Cerebral Protection SystemDeploy a Sentinel cerebral protection device during TAVR for patient with aortic stenosis. | Device | – |
| MRIPatients receive head MRI before and after the surgery in order to determine the stroke incidence. | Diagnostic test | – |
Primary outcome
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)
All stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) through 72 hours post TAVR procedure or discharge (whichever comes first), as adjudicated by an independent Clinical Events Committee (CEC) and using Neurologic Academic Research Consortium (NeuroARC) definitions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yongquan Xie principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Transcatheter Aortic Valve Replacement (TAVR), run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.