title: Comparison between three types of stented pericardial aortic valves (Trivalve trial): study protocol for a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01522352.
authors.affiliation: Heart Surgery Department, Clermont-Ferrand University Hospital, Clermont-Ferrand, France. kazarnoush@chu-clermontferrand.fr.
authors.forename: Kasra
authors.initials: K
authors.lastname: Azarnoush
authors.forename: Bruno
authors.initials: B
authors.lastname: Pereira
authors.forename: Christian
authors.initials: C
authors.lastname: Dualé
authors.forename: Enrica
authors.initials: E
authors.lastname: Dorigo
authors.forename: Mehdi
authors.initials: M
authors.lastname: Farhat
authors.forename: Andrea
authors.initials: A
authors.lastname: Innorta
authors.forename: Nicolas
authors.initials: N
authors.lastname: Dauphin
authors.forename: Etienne
authors.initials: E
authors.lastname: Geoffroy
authors.forename: Pascal
authors.initials: P
authors.lastname: Chabrot
authors.forename: Lionel
authors.initials: L
authors.lastname: Camilleri
mesh_terms: D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D001705:Bioprosthesis; D002985:Clinical Protocols; D005602:France; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation*; D006439:Hemodynamics; D006801:Humans; D011446:Prospective Studies; D011474:Prosthesis Design; D012107:Research Design; D015607:Stents; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D014463:Ultrasonography