The Sentinel Registry (Sentinel)

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Disease; Transcatheter Aortic Valve Replacement; Transcatheter Aortic Valve Implantation
• Intervention / Treatment: Device: Sentinel

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Jung-hee Ham, Project manager; Phone Number: 82-2-3010-4728; Email: cvcrc5@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Recruiting
    • Bucheon Sejong Hospital
    • Contact: Young-jin Choi, MD
    • Principal Investigator: Young-jin Choi, MD
  • Daegu, Korea, Republic of
    • Completed
    • Keimyung University Dongsan Medical Center
  • Gwangju, Korea, Republic of
    • Completed
    • Chonnam National University Hospital
  • Seongnam, Korea, Republic of
    • Withdrawn
    • Bundang CHA Hospital
  • Seongnam-si, Korea, Republic of
    • Completed
    • Seoul university Bundang hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
    • Contact: Seung-hyuk Choi, MD
    • Principal Investigator: Seung-hyuk Choi, MD
  • Seoul, Korea, Republic of
    • Completed
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Completed
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Completed
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of
    • Completed
    • Severance Hospital
  • Yangsan, Korea, Republic of
    • Not yet recruiting
    • Pusan National University Yangsan Hospital
    • Contact: Jun-hong Kim, MD
    • Principal Investigator: Jun-hong Kim, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Undergoing TAVR(transcatheter aortic valve replacement) with the use of SENTINEL embolic protection device

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TAVR; Undergoing transcatheter aortic valve replacement patients	Device: Sentinel; cerebral protection devices during transfemoral transcatheter aortic valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
The event rate of death from any cause	1 month
The event rate of cardiac death	1 month
The event rate of stroke	1 month
The event rate of myocardial infarction	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 acute kidney injury	1 month
The event rate of repeat hospitalization	1 month

Collaborators and Investigators

• Sponsor: Duk-Woo Park, MD
• Collaborators: Boston Scientific Corporation; CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Estimated): February 15, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Cerebral protection
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: AMCCV 2022-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No