Quantification of Debris Captured Using TCEP During VIV TAVR With BVF

Status Recruiting

Clinical Trial Summary

The objective of this study is to quantify the amount of debris captured by the SENTINEL transcatheter cerebral embolic protection (TCEP) device in patients undergoing valve in valve transcatheter aortic valve replacement (VIV TAVR) with bioprosthetic valvular fracture (BVF)

Clinical Trial Description

SENTINEL VIV-TAVR is a prospective, single-center, single-arm, unblinded pilot trial. A total of 20 subjects with severe symptomatic bioprosthetic aortic valve degeneration, who are deemed to be at high or prohibitive mortality risk related to surgical aortic valve replacement, and are undergoing VIV-TAVR and BVF, will be enrolled at the Mid-America Heart Institute, St-Luke's Hospital of Kansas City. Subjects will initially have an aortic arch angiogram done to confirm appropriate anatomy, followed by the SENTINEL device implanted through right radial artery approach. After that, patients will undergo VIV TAVR, using a commercially available transcatheter heart valve, followed by bioprosthetic valve fracture (BVF) as indicated. ;

Study Design

Related Conditions & MeSH terms

Aortic Valve Disease

Clinical Trial Details

NCT number	NCT05093764
Study type	Interventional
Source	Saint Luke's Health System
Contact	Sheila Erwin, RN
Phone	816-932-7996
Email	serwin@saintlukeskc.org
Status	Recruiting
Phase	N/A
Start date	March 2, 2022
Completion date	December 31, 2025

View Details

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