Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR

VOYAGER CE Clinical Trial : Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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