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RecruitingNCT07193888

Navitor Japan Study

Navitor Japan Post-Market Study

Sponsor

Abbott Medical Devices

Enrollment

100 participants

Start Date

Oct 30, 2025

Study Type

OBSERVATIONAL

Conditions

Severe aortic stenosis

Summary

The Navitor Japan Study is designed to evaluate the safety and performance of the Navitor™ valve used in combination with the FlexNav™ delivery system in a contemporary, real-world setting.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria3

  • 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

Exclusion Criteria7

  • 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.

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Interventions

DEVICENavitor Transcatheter Aortic Valve Implantation

Subjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System.

Locations(1)

Osaka Keisatsu Hospital

Osaka, Japan

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NCT07193888

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