Overview
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
Description
The VISTA Study will evaluate the safety, performance, and long-term durability of the Navitor valve in a real-world setting.
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 (Investigational Review Board)/EC (Ethics Committee) of the respective 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