NCT04131127

Sentinel Low Risk Registry

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: CVPath Institute Inc. · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Sentinel Device	Sentinel Device used during TAVI in a Low Risk Patient

Timeline

• Start date: 2020-01-07
• Primary completion: 2020-08-19
• Completion: 2020-08-19
• First posted: 2019-10-18
• Last updated: 2020-10-19

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study