Brief Title
Sentinel Low Risk Registry
Official Title
Cerebral Protection of Acute Embolic Burden During Transcatheter Aortic Valve Implantation in Low Risk Patients
Brief Summary
This registry is designed to quantify embolic debris capture rate in patients at low surgical
risk treated with the Sentinel System during TAVI.
Detailed Description
The SENTINEL-LIR Study is a multicenter, prospective registry to observe rate and type of
debris capture in subjects at low surgical risk undergoing TAVI to demonstrate the positive
effects of the use of the Sentinel System. Histopathology of captured debris from the
Sentinel System will be analyzed.
The primary objective is to determine the presence or absence of particles of 7 discreet
tissue types: acute thrombus (with or without associated tissue/foreign material), organizing
thrombus, valve tissue, arterial wall/necrotic core, calcification, foreign material, and
myocardium. Morphometric assessment of the debris (sizes >150 m, >500 m, and >1,000 m).
Patients will be screened for inclusion and exclusion criteria and documents which will have
been reviewed and approved by the local Ethics Committee or regulatory authority prior to
undergoing any study related exams or procedures.
Fifty (50) subjects will be enrolled in the study from an estimated 6 different sites.
Study Type
Observational [Patient Registry]
Primary Outcome
The SENTINEL-LIR Study
Condition
Aortic Valve Stenosis
Intervention
Sentinel Device
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
50
Start Date
January 7, 2020
Completion Date
August 19, 2020
Primary Completion Date
August 19, 2020
Eligibility Criteria
Inclusion Criteria:
1. Severe symptomatic aortic valve stenosis
2. Planned use of Sentinel System
3. Subject planned for transfemoral TAVI with valve system approved by U.S. FDA for low
risk patients
4. STS-PROM score of less than 4% and agreement by Heart Team that patients meet criteria
for low surgical risk
Exclusion Criteria:
1. Current or recent cerebrovascular accident (stroke, TIA) <6 months
2. Transapical, direct aortic or subclavian TAVI access
3. Carotid stenting or endarterectomy in last 6 weeks
4. Prior aortic valve replacement
5. Concomitant procedure with TAVI such as CABG, PCI, etc.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Aloke V Finn, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04131127
Organization ID
CP2561-0316
Responsible Party
Sponsor
Study Sponsor
CVPath Institute Inc.
Collaborators
Boston Scientific Corporation
Study Sponsor
Aloke V Finn, MD, Principal Investigator, CVPath Institute
Verification Date
October 2020