Actively Recruiting
Navitor Japan Post-Market Study Evaluating Safety and Performance of Navitor Valve with FlexNav Delivery System for Severe Aortic Stenosis
Led by Abbott Medical Devices · Updated on 2026-05-26
100
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the Navitor valve used with the FlexNav delivery system in Japanese patients with symptomatic, severe aortic stenosis. This observational study is designed to understand how the Navitor TAVI system works in real-world settings, including future versions as they become available in Japan. Approximately 100 patients will participate to help assess the device's use after approval. Participants will undergo transcatheter aortic valve implantation (TAVI) using the Navitor valve, FlexNav Delivery system, and Navitor Loading System. This single-arm study will follow patients after their procedure, with check-ins at hospital discharge, 30 days, and one year later to monitor safety and device performance over time. During the study, patients will attend scheduled follow-up visits to assess outcomes and any potential issues. Researchers will monitor safety and performance endpoints 30 days after the procedure and continue to observe patients for up to one year. The study aims to gather detailed information on how well the device works and its safety in everyday clinical practice.
CONDITIONS
Brief 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.
- Patient has been informed of the study details and provided written informed consent.
- Patient and 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.
- Life expectancy less than 12 months due to non-cardiac conditions.
- Medical, social, or psychological conditions limiting participation or compliance.
- Known contraindication or sensitivity to CT or contrast media that cannot be premedicated.
- Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy.
- Currently in another investigational drug or device study that may confound results.
- Anatomy that makes insertion and access to the aortic valve difficult or impossible.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of procedure
Participants undergo transcatheter aortic valve implantation (TAVI) with the Navitor valve using the FlexNav Delivery system.
1 procedure visit (in-person)
Duration - Up to 1 year after the procedure
Participants are followed up after the procedure to assess safety and performance of the Navitor TAVI system.
Visits at discharge, 30 days, and 1 year post-procedure (3 visits total)
Trial Site Locations
Total: 3 locations
1
Kokura Memorial Hospital
Fukuoka, Japan
Actively Recruiting
2
Shonan Kamakura General Hospital
Kanagawa, Japan
Actively Recruiting
3
Osaka Keisatsu Hospital
Osaka, Japan
Actively Recruiting
Research Team
B
Bart Janssens
A
Alicia Kimber
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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