Aortic Valve Stenosis Clinical Trial
Official title:
Transluminal Aortic Balloon Valvuloplasty Registry (TAB-R)
This registry is designed to monitor the real world clinical performance and safety of the V8 device used to perform balloon aortic valvuloplasty (BAV). Additional analyses or calculations may be obtained from the imaging or evaluations already performed per the sites' standard of care
The study is an open-label observational study involving a minimum of 10 centers. A minimum
of 100 patients, including a minimum of 30 stand-alone balloon aortic valvuloplasty (BAV)
treatment patients, will be enrolled. Enrollment will continue until all 3 of these
conditions are met.
BAV-only patients will be followed through a 6-month post-treatment telephone follow up.
Patients treated with the V8 device for BAV as a bridge to transcatheter aortic valve
replacement (TAVR) or surgical aortic valve replacement (SAVR) or as an intraprocedural
predilatation prior to TAVR, will exit the study at the time of the TAVR or SAVR implant or
at 6 months post-BAV treatment, whichever comes first.
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Observational Model: Case-Only, Time Perspective: Prospective
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