Status:
RECRUITING
Navitor Japan Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Severe Aortic Stenosis
Eligibility:
All Genders
18-100 years
Brief 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.
Detailed Description
A prospective, single-arm, observational, multicenter post-market clinical study enrolling approximately 100 Japanese patients with symptomatic, severe aortic stenosis. The study will evaluate the saf...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07193888
Start Date
October 30 2025
End Date
March 1 2027
Last Update
November 24 2025
Active Locations (1)
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1
Osaka Keisatsu Hospital
Osaka, Japan