Abbott registers VOYAGER CE trial for Encantor TAVI System in aortic stenosis
Abbott Medical Devices listed a new pre-market study of its Encantor transcatheter aortic valve device, not yet recruiting, with an estimated 2028 primary completion.
Abbott Medical Devices added a new trial registration for its Encantor TAVI System this period.
- The "VOYAGER CE" study (NCT07696182) is a prospective, single-arm, multi-center, pre-market clinical investigation designed to evaluate the safety and performance of the Encantor TAVI System.1 The 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.1 The study is listed as not yet recruiting, with planned enrollment of 150 participants (estimated)1 and a primary outcome of composite of all-cause mortality or all strokes at 12 months post index.1
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