Sentinel Low Risk Registry

Completed

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT04131127
• Lead Sponsor: CVPath Institute Inc.

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 Timeline

• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-18
• Study Start: 2020-01-07
• Primary Completion: 2020-08-19
• Study Completion: 2020-08-19
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-16
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

UPMC Pinnacle; 🇺🇸 Wormleysburg, Pennsylvania, United States