Aortic Valve DiseaseSentinelNCT05217888
The Sentinel Registry
An observational study of Aortic Valve Disease and Transcatheter Aortic Valve Implantation, run by Duk-Woo Park, MD at 10 sites in South Korea.
Trial summary
This registry is to evaluate procedural outcomes and safety outcomes of cerebral protection devices during transfemoral TAVR in real-world clinical practice. The data from this registry will be compared with the extracted data from the TP TAVR registry(NCT038262664) using Propensity Score Matching. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Aortic Valve Disease, Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement
- What is being tested?
- Sentinel
- Type of treatment
- Medical device
- How many people
- 158 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 18 May 2022to 20 May 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Undergoing TAVR(transcatheter aortic valve replacement) with the use of SENTINEL embolic protection device
Who may be able to join
- Age 19 and more
- Undergoing TAVR with the use of SENTINEL embolic protection device
- Higher risk of cerebrovascular embolic events (any of the followings)
- Bicuspid aortic valve
- Calcified lesion or atherosclerosis in the ascending aorta and/or aortic arch
- Heavy calcified aortic valve (Ca. volume > 500)
Show all 11Show fewer
- Chronic kidney disease
- Prior stroke
- Stroke risk is strongly anticipated by attending physicians
- Compatible carotid and brachiocephalic artery anatomy for SENTINEL device as determined by Multi-Slice Computed Tomography scan or equivalent imaging modality
- Agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Who cannot join
- Vasculature in the right extremity precluding radial or brachial access
- Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel System access and insertion
- Inadequate circulation to the right extremity as evidenced by signs of artery occlusion (modified Allen's test) or absence of radial/brachial pulse
- Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature
- Symptomatic or asymptomatic severe occlusive carotid disease requiring concomitant carotid endarterectomy/stenting
- Undergone carotid stenting or carotid endarterectomy within the previous 6 weeks
- Concurrent medical condition with a life expectancy of less than 1 year
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Bucheon Sejong Hospital
Bucheon-si
Keimyung University Dongsan Medical Center
Daegu
Chonnam National University Hospital
Gwangju
Seoul university Bundang hospital
Seongnam-si
Asan Medical Center
Seoul
Korea University Anam Hospital
Seoul
Samsung medical center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
Pusan National University Yangsan Hospital
Yangsan
About this study
Official title: Evaluation of Procedural Outcomes and Safety of Cerebral Embolic Protection Device for Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement in Routine Clinical Practice, A Multicenter, Prospective Observational Study
This registry is to evaluate procedural outcomes and safety outcomes of cerebral protection devices during transfemoral TAVR in real-world clinical practice.
The data from this registry will be compared with the extracted data from the TP TAVR registry(NCT038262664) using Propensity Score Matching.
- Conditions
- Aortic Valve Disease, Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement
- Being tested
- Sentinel
- Keywords
- Cerebral protection
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SentinelDevice
cerebral protection devices during transfemoral transcatheter aortic valve replacement
| Study group | Role | What they receive |
|---|---|---|
| TAVR | Undergoing transcatheter aortic valve replacement patients Receives: Device: Sentinel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of procedural success
Procedural Success: Sentinel system acute delivery and retrieval (categorized as successful deployment of both filters, 1 filter, or no filter and retrieval of the system)
Procedural outcomes
- Procedure time(min)
- Positioning time
- Total fluoroscopy time
- Total contrast used
- Total procedure index time
- Sentinel access site vascular complications related to the procedure (major and minor)
Measured: 1 month
Secondary outcomes (9)
The event rate of death from any cause
Measured: 1 month
The event rate of cardiac death
Measured: 1 month
The event rate of stroke
Measured: 1 month
The event rate of myocardial infarction
Measured: 1 month
The event rate of systemic embolic event
Measured: 1 month
The event rate of vascular complication
Measured: 1 month
The event rate of bleeding
Measured: 1 month
The event rate of acute kidney injury
Measured: 1 month
The event rate of repeat hospitalization
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start18 May 2022
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- 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
- 158 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Duk-Woo Park, MD
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, Boston Scientific Corporation
- Responsible party
- Sponsor-investigator, Duk-Woo Park, MD, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217888
- Sponsor's protocol ID
- AMCCV 2022-01
- Acronym
- Sentinel
- Status last verified
- Jun 2025
- First submitted
- 17 Jan 2022
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Park HS, Suh CH, Ahn JM, Kang DY, Ahn SY, Wee SB, Lee SH, Seo KW, Kim MJ, Park SJ, Park DW. Effect of cerebral embolic protection device on new cerebral embolism during transcatheter aortic valve replacement: A prospective sentinel registry. Am Heart J. 2026 Jan;291:44-52. doi: 10.1016/j.ahj.2025.08.006. Epub 2025 Aug 14.
PubMed 40816554
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Procedural Outcomes and Safety of Cerebral Embolic Protection Device for Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement in Routine Clinical Practice, A Multicenter, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05217888
- Acronym / sponsor ID
- Sentinel / AMCCV 2022-01
- Conditions
- Aortic Valve Disease, Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement
- Keywords
- Cerebral protection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Duk-Woo Park, MDUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, Boston Scientific Corporation
- Study start
- 18 May 2022 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 1 Feb 2022 (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.
This registry is to evaluate procedural outcomes and safety outcomes of cerebral protection devices during transfemoral TAVR in real-world clinical practice.
The data from this registry will be compared with the extracted data from the TP TAVR registry(NCT038262664) using Propensity Score Matching.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVR | – | Device: SentinelUndergoing transcatheter aortic valve replacement patients |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Undergoing TAVR(transcatheter aortic valve replacement) with the use of SENTINEL embolic protection device
Key inclusion criteria (11 listed)
- Age 19 and more
- Undergoing TAVR with the use of SENTINEL embolic protection device
- Higher risk of cerebrovascular embolic events (any of the followings)
- Compatible carotid and brachiocephalic artery anatomy for SENTINEL device as determined by Multi-Slice Computed Tomography scan or equivalent imaging modality
- Agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Key exclusion criteria (7 listed)
- Vasculature in the right extremity precluding radial or brachial access
- Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel System access and insertion
- Inadequate circulation to the right extremity as evidenced by signs of artery occlusion (modified Allen's test) or absence of radial/brachial pulse
- Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature
- Symptomatic or asymptomatic severe occlusive carotid disease requiring concomitant carotid endarterectomy/stenting
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 |
|---|---|---|
| Sentinelcerebral protection devices during transfemoral transcatheter aortic valve replacement | Device | TAVR |
Primary outcome
The rate of procedural success
Time frame: 1 month
Procedural Success: Sentinel system acute delivery and retrieval (categorized as successful deployment of both filters, 1 filter, or no filter and retrieval of the system) Procedural outcomes * Procedure time(min) * Positioning time * Total fluoroscopy time * Total contrast used * Total procedure index time * Sentinel access site vascular complications related to the procedure (major and minor)
9 secondary outcomes
The event rate of death from any cause
Time frame: 1 month
The event rate of cardiac death
Time frame: 1 month
The event rate of stroke
Time frame: 1 month
The event rate of myocardial infarction
Time frame: 1 month
The event rate of systemic embolic event
Time frame: 1 month
The event rate of vascular complication
Time frame: 1 month
The event rate of bleeding
Time frame: 1 month
The event rate of acute kidney injury
Time frame: 1 month
The event rate of repeat hospitalization
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Derived from this study: PubMed 40816554Park HS, Suh CH, Ahn JM, Kang DY, Ahn SY, Wee SB, Lee SH, Seo KW, Kim MJ, Park SJ, Park DW. Effect of cerebral embolic protection device on new cerebral embolism during transcatheter aortic valve replacement: A prospective sentinel registry. Am Heart J. 2026 Jan;291:44-52. doi: 10.1016/j.ahj.2025.08.006. Epub 2025 Aug 14.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease and Transcatheter Aortic Valve Implantation, run by Duk-Woo Park, MD at 10 sites in South Korea.
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 11 inclusion and 7 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: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 procedural success (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05217888, which also lists 1 linked publication.
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 13 Jun 2025.