Post-Market Clinical Follow Up Study With Navitor Valve

Summary

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

Eligibility

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

Conditions2

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