VISTA Post-Market Clinical Study

Not yet recruiting

Recruitment & Eligibility

Inclusion Criteria

The patient is scheduled to undergo a Navitor TAVI procedure.
The patient has been informed of the nature of the study, agrees to its provisions,and has provided written informed consent as approved by the IRB (InvestigationalReview Board)/EC (Ethics Committee) of the respe ctive clinical site.
The patient and the treating physician agree that the subject will return for all required post procedure follow up visits.

Exclusion Criteria

Life expectancy < 12 months from the time of informed consent due to non-cardiac co-morbid conditions.

In the judgment of the Investigator, patient presents with a medical, social, or psychological condition that could limit the ability or willingness to participate in the study, comply with study required testing and/or follow-up visits or that could impact scientific integrity of the study.
Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated.
Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be adequately premedicated.
Currently participating in an investigational drug or device study that may confound the results of this study

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method