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
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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