VOYAGER CE Clinical Study using the Encantor TAVI System.
Subject identified as appropriate for transcatheter heart valve intervention therapy for the treatment of symptomatic, severe aortic stenosis.
Subject is of legal age for consent (18 years old).
Willing to return for required follow-up visits and assessments
Pregnant or nursing subjects.
Need for emergency surgery for any reason
Anatomic or comorbid conditions
Currently participating in an investigational drug or device study that has not reached the primary endpoint or may confound the results of this trial
Single group
Prospective, single-arm, multi-center study.
DeviceThis 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
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This trial is not recruiting at the moment. You can still explore other options:
