A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm
Recruiting
Observational Study
Aortic Stenosis
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Sex
- Any
- Study type
- Observational
- Participants needed
- 290 (estimated)
- Sponsor
- World Health Research Inc. · Industry
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About This Trial
The goal of this study is to learn what effects the ABC Bicuspid Sizing Algorithm has on the clinical outcomes of patients with bicuspid aortic stenosis after having a transcatheter aortic valve replacement (TAVR) using the Sapien 3 valve. The main questions the study aims to answer are:
1. Does the ABC Bicuspid Sizing Algorithm increase the technical success at exit from the procedure room?
2. D…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Have bicuspid aortic valve disease
* Have severe aortic stenosis or mixed aortic stenosis and regurgitation requiring treatment
* Have no other condition requiring surgical intervention
* Have had a TAVR CT scan (retrospectively gated contrast enhanced acquisition) that is of …
Contacts