Quantification of Debris Captured Using TCEP During VIV TAVR With BVF

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

March 2, 2022

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2025

Conditions
Aortic Valve Disease
Interventions
DEVICE

VIV TAVR with BVF using TCEP

The insertion and retrieval of the SENTINEL device is performed at the time of the patients TAVR procedure in the same setting while they are sedated under moderate sedation or general anesthesia depending on the case. The device is inserted at the initiation of the procedure through 6F right radial artery access and the filters are positioned in the left common carotid artery and brachiocephalic artery. After deployment, the usual TAVR procedure is performed. At the conclusion of the procedure, the SENTINEL device is extracted and hemostasis is achieved at the radial access site in the usual fashion with patent hemostasis.

Trial Locations (1)

64111

RECRUITING

Saint Luke's Hospital of Kansas City, Kansas City

Sponsors
All Listed Sponsors
collaborator

Boston Scientific Corporation

INDUSTRY

lead

Saint Luke's Health System

OTHER