Valvular & structural heart disease

Transcatheter aortic valve implantation versus surgical aortic valve replacement in patients at low to intermediate surgical risk: rationale and design of the randomised DEDICATE Trial

EuroInterventionPublished Rationale and design of a randomised controlled trial

Study context

Population
Low- to intermediate-risk patients aged ≥65 years with severe AS, eligible for both transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) by the Heart Teamapproximately
Participants
1,404 participants
Planned comparison
TAVI vs SAVR
Primary endpoint
Composite of:
  • Mortality
  • Stroke
Follow-up
1 year and 5 years
Methodological detailsinvestigator-initiated, prospective, multicentre, sequential non-inferiority and superiority testing, Procedures per local best practice with contemporary routine devices
  • Investigator-initiated
  • Prospective
  • Multicentre
  • Sequential non-inferiority and superiority testing
  • Procedures per local best practice with contemporary routine devices

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

Original publication

Transcatheter aortic valve implantation versus surgical aortic valve replacement in patients at low to intermediate surgical risk: rationale and design of the randomised DEDICATE Trial. EuroIntervention. Published 23 October 2023. doi:10.4244/eij-d-23-00232

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