Valvular & structural heart disease
Transfemoral transcatheter aortic valve replacement with VitaFlowTM valve for pure native aortic regurgitation in patients with high surgical risk: Rationale and design of a prospective, multicenter, and randomized SEASON-AR trial
Study context
- Population
- Patients with pure native severe aortic regurgitation (AR) and high surgical riskplanned enrolment 210
- Planned comparison
- Transfemoral transcatheter aortic valve replacement (TAVR) with VitaFlow valve + guideline-directed medical therapy (GDMT) vs GDMT alone
- Primary endpoint
- Major adverse cardiac events (MACE):
- All-cause mortality
- Disabling stroke
- Rehospitalization for HF
- Follow-up
- 12 months after the procedure
Methodological detailsrationale and design, prospective, multicentre, parallel-group, open-label, 1:1 randomisation, at least 20 sites in China, Follow-up at 1, 6 and 12 months after discharge, then annually until 5 years
- Rationale and design
- Prospective
- Multicentre
- Parallel-group
- Open-label
- 1:1 randomisation
- At least 20 sites in China
- Follow-up at 1, 6 and 12 months after discharge, then annually until 5 years
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Transfemoral transcatheter aortic valve replacement with VitaFlowTM valve for pure native aortic regurgitation in patients with high surgical risk: Rationale and design of a prospective, multicenter, and randomized SEASON-AR trial. Am Heart J. Published 25 February 2024. doi:10.
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