Study Protocol for Transcatheter Aortic Valve Replacement for a Degenerated Aortic Bioprosthesis in a Japanese Cohort.

ABSTRACT: Background: The valve-in-valve (VIV) procedure is being increasingly performed in high-risk patients with a degenerated bioprosthesis in an aortic position in Western countries. The early safety and efficacy of the VIV procedure, however, remain unclear in Japanese patients with a small aortic annulus. We present the protocol for a study designed to evaluate the early safety and efficacy of the VIV procedure in the aortic position in Japanese patients. Methods and Results: The prospective, single-center, non-comparative, clinical study of the VIV procedure for the aortic position (AORTIC VIV study) commenced in August 2016 and will end in March 2020. Patients will be monitored for ≥1 month after the VIV procedure. The targeted number of patients is 11. Eligibl

SUBMITTER: Yamashita K 

PROVIDER: S-EPMC7890281 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature