Sentinel Low Risk Registry

Overview

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

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

Interventions

Eligibility

Locations (4)

Outcomes