Transaortic transcatheter aortic valve implantation - rationale and design of the multicenter, multinational prospective ROUTE registry.

ABSTRACT:

Background

Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed approach that provides an alternative delivery route for valve replacement in patients with vascular abnormalities or existing comorbidities. While initial studies have shown the principal efficacy and safety, the real world effectiveness and safety of this approach remains to be fully assessed.

Methods/design

In this regard, the Registry Of the Utilization of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) represents the first multicenter, multinational prospective documentation of the course and outcome of patients with severe calcific aortic stenosis (AS) undergoing TAo-TAVI. ROUTE commenced in February 2013 with the goal of consecutively enrolling 300 patients a

SUBMITTER: Bramlage P 

PROVIDER: S-EPMC4271489 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature