Open Access Study protocol

Comparison between three types of stented pericardial aortic valves (Trivalve trial): study protocol for a randomized controlled trial

Kasra Azarnoush12*, Bruno Pereira3, Christian Dualé4, Enrica Dorigo1, Mehdi Farhat1, Andrea Innorta1, Nicolas Dauphin1, Etienne Geoffroy1, Pascal Chabrot5 and Lionel Camilleri1

Author Affiliations

1 Heart Surgery Department, Clermont-Ferrand University Hospital, Clermont-Ferrand, France

2 INRA, UMR 1019 Nutrition Humaine, F-63122 Saint Genès Champanelle, France

3 Biostatistics Unit, Délégation Recherche Clinique & Innovation, Clermont-Ferrand University Hospital, Clermont-Ferrand, France

4 Centre de Pharmacologie Clinique (Inserm CIC 501), Clermont-Ferrand University Hospital, Clermont-Ferrand, France

5 Radiology Department, Clermont-Ferrand University Hospital, Clermont-Ferrand, France

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Trials 2013, 14:413  doi:10.1186/1745-6215-14-413

Published: 3 December 2013

Abstract

Background

Aortic valve stenosis is one of the most common heart diseases in older patients. Nowadays, surgical aortic valve replacement is the ‘gold standard’ treatment for this pathology and the most implanted prostheses are biological ones. The three most implanted bovine bioprostheses are the Trifecta valve (St. Jude Medical, Minneapolis, MN, USA), the Mitroflow valve (Sorin Group, Saluggia, Italy), and the Carpentier-Edwards Magna Ease valve (Edwards Lifesciences, Irvine, CA, USA). We propose a randomized trial to objectively assess the hemodynamic performances of these bioprostheses.

Methods and design

First, we will measure the aortic annulus diameter using CT-scan, echocardiography and by direct sizing in the operating room after native aortic valve resection. The accuracy of information, in terms of size and spatial dimensions of each bioprosthesis provided by manufacturers, will be checked. Their hemodynamic performances will be assessed postoperatively at the seventh day and the sixth month after surgery.

Discussion

This prospective controlled randomized trial aims to verify and compare the hemodynamic performances and the sizing of these three bioprostheses. The data obtained may help surgeons to choose the best suitable bioprosthesis according to each patient’s morphological characteristics.

Trial registration

ClinicalTrials.gov Identifier: NCT01522352

Keywords:
Stented pericardial aortic valves; Pericardial aortic valves; Hemodynamic performance