VOYAGER CE Clinical Study using the Encantor TAVI System.
The VOYAGER CE trial is a prospective, single-arm, multi-center, pre-market clinical investigation designed to evaluate the safety and performance of the Encantor TAVI System. This clinical trial will enroll subjects who have symptomatic heart disease due to severe native calcific aortic stenosis and who are judged by a heart team to be appropriate for transcatheter valve replacement therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
This intervention is distinguished by the use of the Encantor TAVI System, a transcatheter valve replacement therapy specifically designed for patients with symptomatic severe native calcific aortic stenosis who are considered appropriate candidates by a multidisciplinary heart team. This device is intended to provide a minimally invasive alternative to surgical aortic valve replacement.
Composite of all-cause mortality or all strokes at 12 months post index
Composite of all-cause mortality or all strokes
Time frame: 12 months post index
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