Valvular & structural heart disease
Design and rationale of the evaluation of transcatheter aortic valve replacement compared to surveillance for patients with asymptomatic severe aortic stenosis: The EARLY transcatheter aortic valve replacement (TAVR) trial
Study context
- Population
- Asymptomatic severe aortic stenosis (AS) with preserved LVEFplanned
- Participants
- 900 participants
- Planned comparison
- TAVR vs clinical surveillance
- Primary endpoint
- Death, stroke or unplanned CV hospitalization
Methodological detailsprospective, multicentre, event-based design, 1:1 randomisation, stratified by ability to perform treadmill stress test, Asymptomatic patients with a positive stress test followed in a registry and undergo AVR per guidelines
- Prospective
- Multicentre
- Event-based design
- 1:1 randomisation
- Stratified by ability to perform treadmill stress test
- Asymptomatic patients with a positive stress test followed in a registry and undergo AVR per guidelines
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Design and rationale of the evaluation of transcatheter aortic valve replacement compared to surveillance for patients with asymptomatic severe aortic stenosis: The EARLY TAVR trial. Am Heart J. Published 4 December 2023. doi:10.
Summarised from the published abstract; every number is checked against it