The Sentinel Registry

Aortic Valve Disease Clinical Trial

— Sentinel  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05217888
• Other study ID #: AMCCV 2022-01
• Status: Recruiting
• Start date: May 18, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: December 2023
• Source: Asan Medical Center
• Contact: Jung-hee Ham, Project manager
• Phone: 82-2-3010-4728
• Email: cvcrc5[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Age 19 and more
• Undergoing TAVR with the use of SENTINEL embolic protection device
• Higher risk of cerebrovascular embolic events (any of the followings)

1. Bicuspid aortic valve

2. Calcified lesion or atherosclerosis in the ascending aorta and/or aortic arch

3. Heavy calcified aortic valve (Ca. volume > 500)

4. Chronic kidney disease

5. Prior stroke

6. 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Aortic Valve Disease
• Transcatheter Aortic Valve Implantation
• Transcatheter Aortic Valve Replacement

Intervention

Device:
• Sentinel
cerebral protection devices during transfemoral transcatheter aortic valve replacement

Locations

Country	Name	City	State
Korea, Republic of	Bucheon Sejong Hospital	Bucheon
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Bundang CHA Hospital	Seongnam
Korea, Republic of	Seoul university Bundang hospital	Seongnam-si
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

Sponsors (3)

Lead Sponsor	Collaborator
Duk-Woo Park, MD	Boston Scientific Corporation, CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 month
Secondary	The event rate of death from any cause		1 month
Secondary	The event rate of cardiac death		1 month
Secondary	The event rate of stroke		1 month
Secondary	The event rate of myocardial infarction		1 month
Secondary	The event rate of systemic embolic event		1 month
Secondary	The event rate of vascular complication		1 month
Secondary	The event rate of bleeding		1 month
Secondary	The event rate of acute kidney injury		1 month
Secondary	The event rate of repeat hospitalization		1 month