Valvular & structural heart disease
BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs: design and rationale of the BASELINE trial
Study context
- Population
- Symptomatic patients with a failing surgical aortic bioprosthesisplanned enrolment
- Participants
- 440 patients
- Planned comparison
- Balloon-expandable SAPIEN-3 Ultra vs self-expanding EVOLUT PRO+ for valve-in-valve transcatheter aortic valve replacement (TAVR)
- Primary endpoint
- VARC-3 device success (technical success, freedom from mortality, freedom from surgery or intervention related to the device or to a major vascular, access-related or cardiac structural complication, with intended valve performance: mean gradient <20 mmHg and less than moderate aortic regurgitation); co-primary at 1 year: all-cause death, disabling stroke, rehospitalization for HF or valve-related problems
- Follow-up
- 30 days
Methodological detailsdesign and rationale, investigator-initiated, prospective, open-label, superiority, multicentre (up to 50 sites in 12 countries, Europe and North America), Independent core laboratories analyse echocardiography, multi-sliced CT and cine-fluoroscopy
- Design and rationale
- Investigator-initiated
- Prospective
- Open-label
- Superiority
- Multicentre (up to 50 sites in 12 countries, Europe and North America)
- Independent core laboratories analyse echocardiography, multi-sliced CT and cine-fluoroscopy
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs: design and rationale of the BASELINE trial. Am Heart J. Published 19 November 2022. doi:10.
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