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BMC Cardiovascular Disorders

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Open Access 01-12-2014 | Study protocol

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

Authors: Peter Bramlage, Mauro Romano, Nikolaos Bonaros, Ricardo Cocchieri, Dariusz Jagielak, Derk Frank, Vinayak Bapat

Published in: BMC Cardiovascular Disorders | Issue 1/2014

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 at up to 22 sites across Europe. The primary objective of ROUTE is to determine the 30-day mortality associated with TAo-TAVI using the Edwards SAPIEN THV (Edwards Lifesciences, Irvine, CA). In addition, ROUTE aims to quantify complications, predictors of patient outcome and the value of CT guided valve sizing.

Discussion

Findings from this landmark registry will provide important information regarding procedural success rates and early mortality in patients undergoing TAo-TAVI.

Trial registration

Identifier: NCT01991431.

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The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2261/14/152/prepub

Title: Transaortic transcatheter aortic valve implantation - rationale and design of the multicenter, multinational prospective ROUTE registry
Authors: Peter Bramlage
Mauro Romano
Nikolaos Bonaros
Ricardo Cocchieri
Dariusz Jagielak
Derk Frank
Vinayak Bapat
Publication date: 01-12-2014
Publisher: BioMed Central
Published in: BMC Cardiovascular Disorders / Issue 1/2014
Electronic ISSN: 1471-2261
DOI: https://doi.org/10.1186/1471-2261-14-152

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Methods/Design

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Trial registration

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