20
Participants
Start Date
March 2, 2022
Primary Completion Date
December 31, 2024
Study Completion Date
December 31, 2025
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.
RECRUITING
Saint Luke's Hospital of Kansas City, Kansas City
Collaborators (1)
Boston Scientific Corporation
INDUSTRY
Saint Luke's Health System
OTHER