Valvular & structural heart disease
Comparison of downsizing strategy (HANGZHOU Solution) and standard annulus sizing strategy in type 0 bicuspid aortic stenosis patients undergoing transcatheter aortic valve replacement: Rationale and design of a randomized clinical trial
Study context
- Population
- Patients with severe type 0 bicuspid aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) (mean gradient ≥40 mmHg, peak jet velocity ≥4.0 m/s, aortic valve area (AVA) ≤1.0 cm², or AVA index ≤0.6 cm²/m²)
- Planned comparison
- Downsizing strategy vs standard annulus sizing strategy in TAVR
- Primary endpoint
- Composite of:
- VARC-3 device success
- Absence of permanent pacemaker implantation due to high-degree AV block
- Absence of new-onset complete left bundle branch block
Methodological detailsrationale and design, prospective, multicentre, superiority, single-blinded, 1:1 randomisation
- Rationale and design
- Prospective
- Multicentre
- Superiority
- Single-blinded
- 1:1 randomisation
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Comparison of downsizing strategy (HANGZHOU Solution) and standard annulus sizing strategy in type 0 bicuspid aortic stenosis patients undergoing transcatheter aortic valve replacement: Rationale and design of a randomized clinical trial. Am Heart J. Published 1 May 2024. doi:10.
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