The Sentinel Registry
- Conditions
- Transcatheter Aortic Valve ImplantationTranscatheter Aortic Valve ReplacementAortic Valve Disease
- Interventions
- Device: Sentinel
- Registration Number
- NCT05217888
- Lead Sponsor
- Duk-Woo Park, MD
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
-
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)
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description TAVR Sentinel Undergoing transcatheter aortic valve replacement patients
- Primary Outcome Measures
Name Time Method The rate of procedural success 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)
- Secondary Outcome Measures
Name Time Method The event rate of death from any cause 1 month The event rate of repeat hospitalization 1 month The event rate of stroke 1 month The event rate of systemic embolic event 1 month The event rate of vascular complication 1 month The event rate of bleeding 1 month The event rate of cardiac death 1 month The event rate of myocardial infarction 1 month The event rate of acute kidney injury 1 month
Trial Locations
- Locations (11)
Bucheon Sejong Hospital
🇰🇷Bucheon, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Seoul university Bundang hospital
🇰🇷Seongnam-si, Korea, Republic of
Bundang CHA Hospital
🇰🇷Seongnam, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Samsung medical center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of