Sentinel Low Risk Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-07

Study Completion Date

2020-08-19

Brief Summary

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This registry is designed to quantify embolic debris capture rate in patients at low surgical risk treated with the Sentinel System during TAVI.

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Detailed Description

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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.

Conditions

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Aortic Valve Stenosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Sentinel Device

Sentinel Device used during TAVI in a Low Risk Patient

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No