Valvular & structural heart disease

Preoperative computed tomography-imaging with patient-specific computer simulation in transcatheter aortic valve implantation: Design and rationale of the GUIDE-TAVI trial

Am Heart JPublished Design and rationale of a randomised controlled trial

Study context

Population
Patients accepted for Transcatheter Aortic Valve Implantation (TAVI) by the Heart Teamplanned
Participants
227 vs 227
Planned comparison
Computed tomography (CT)-based patient-specific computer simulation (FEops HEARTGuide (FHG)) plus routine CT vs routine CT alone before TAVI
  • FHGn = 227
  • No FHGn = 227reference
Primary endpoint
Incidence of mild to severe PVR (VARC-3)
Methodological detailsinternational, multicentre, Secondary endpoints: new conduction disorders requiring permanent pacemaker, preoperative vs final valve size, target vs final implantation depth, change of preoperative decision, failure to implant valve, early safety composite, quality of life
  • International
  • Multicentre
  • Secondary endpoints: new conduction disorders requiring permanent pacemaker, preoperative vs final valve size, target vs final implantation depth, change of preoperative decision, failure to implant valve, early safety composite, quality of life

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

Preoperative computed tomography-imaging with patient-specific computer simulation in transcatheter aortic valve implantation: Design and rationale of the GUIDE-TAVI trial. Am Heart J. Published 30 December 2023. doi:10.1016/j.ahj.2023.12.017

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