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Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
Sponsor: Abbott Medical Devices
Summary
VOYAGER CE Clinical Study using the Encantor TAVI System.
Official title: VOYAGER CE Clinical Trial : Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-11-30
Completion Date
2038-12-30
Last Updated
2026-07-10
Healthy Volunteers
No
Conditions
Interventions
Prospective, single-arm, multi-center study.
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.