Actively Recruiting
Navitor Japan Study
Led by Abbott Medical Devices · Updated on 2025-11-24
100
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Navitor Japan Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU).
- Life expectancy less than 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Osaka Keisatsu Hospital
Osaka, Japan
Actively Recruiting
Research Team
B
Bart Janssens
CONTACT
A
Alicia Kimber
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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