Post-Market Clinical Follow Up Study With Navitor Valve

VISTA Nova Study (Navitor Post-Market Clinical Follow Up Study)

Evaluation of the safety and performance of the Navitor TAVI System in a Global Study

The VISTA Nova Study will evaluate the safety, performance, and long-term durability of the Navitor valve in a real-world setting.

Inclusion Criteria:

• Patient is eligible per the current approved indication after Heart Team discussion and intended 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:

• Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU)
• 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
• Anatomy that makes insertion and endovascular access to the aortic valve difficult and/or impossible