Navitor Japan Study

Who can take part

• 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 EC 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

Who cannot take part

• 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
• 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
• Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU)
• Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated
• Anatomy that makes insertion and endovascular access to the aortic valve difficult and/or impossible