title: Rationale and design of the Edwards SAPIEN-3 periprosthetic leakage evaluation versus Medtronic CoreValve in transfemoral aortic valve implantation (ELECT) trial : A randomised comparison of balloon-expandable versus self-expanding transcatheter aortic valve prostheses.
abstract: OBJECTIVE
  Periprosthetic aortic regurgitation (PPR) after transcatheter aortic valve implantation (TAVI) remains an important issue associated with impaired long-term outcomes. The current randomised study aims to evaluate potential differences between the balloon-expandable Edwards SAPIEN-3 and the self-expanding Medtronic CoreValve system with the main focus on post-TAVI PPR by means of novel imaging endpoints, and an additional focus on other clinical endpoints.
  
  
  METHODS
  The primary endpoint of this study is quantitative assessment of the severity of post-procedural PPR using cardiac magnetic resonance imaging. Several other novel imaging modalities (X-ray contrast angiography, echocardiography) are used as secondary imaging modalities for the assessment of PPR following TAVI. Secondary objectives of the study include clinical outcomes such as cerebral and kidney injury related to TAVI, and quality of life.
  
  
  METHODS
  The ELECT study is a single-centre, prospective, two-armed randomised controlled trial. For the purpose of this study, 108 consecutive adult patients suitable for transfemoral TAVI will be randomly allocated to receive the SAPIEN-3 (n = 54) or the CoreValve system (n = 54).
  
  
  CONCLUSIONS
  The ELECT trial is the first randomised controlled trial to quantitatively compare the extent of post-TAVI PPR between the SAPIEN-3 and CoreValve. Furthermore, it will evaluate potential differences between the two prostheses with regard to mid-term clinical outcome and quality of life.
authors.affiliation: Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: M
authors.initials: M
authors.lastname: Abawi
authors.affiliation: Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.|Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: P
authors.initials: P
authors.lastname: Agostoni
authors.affiliation: Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: N H M
authors.initials: NHM
authors.lastname: Kooistra
authors.affiliation: Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: M
authors.initials: M
authors.lastname: Samim
authors.affiliation: Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: F
authors.initials: F
authors.lastname: Nijhoff
authors.affiliation: Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: M
authors.initials: M
authors.lastname: Voskuil
authors.affiliation: Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: H
authors.initials: H
authors.lastname: Nathoe
authors.affiliation: Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: P A
authors.initials: PA
authors.lastname: Doevendans
authors.affiliation: Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: S A
authors.initials: SA
authors.lastname: Chamuleau
authors.affiliation: Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: K
authors.initials: K
authors.lastname: Urgel
authors.affiliation: Department of Radiology, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: J
authors.initials: J
authors.lastname: Hendrikse
authors.affiliation: Department of Radiology, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: T
authors.initials: T
authors.lastname: Leiner
authors.affiliation: Department of Nephrology and Hypertension, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: A C
authors.initials: AC
authors.lastname: Abrahams
authors.affiliation: Department of Neurology, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: B
authors.initials: B
authors.lastname: van der Worp
authors.affiliation: Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands. p.stella@umcutrecht.nl.
authors.forename: P R
authors.initials: PR
authors.lastname: Stella
keywords: CoreValve; Periprosthetic aortic regurgitation; SAPIEN-3; Transcatheter aortic valve implantation