Sentinel Low Risk Registry

Cerebral Protection of Acute Embolic Burden During Transcatheter Aortic Valve Implantation in Low Risk Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04131127

Enrollment

Registered

2019-10-18

Start date

2020-01-07

Completion date

2020-08-19

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

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.

Interventions

DEVICESentinel Device

Sentinel Device used during TAVI in a Low Risk Patient

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The SENTINEL-LIR Study	12 months	To determine the incidence and type of debris capture in SENTINEL devices deployed during TAVI in patients at low surgical risk

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026