Navitor Japan Study
NCT07193888 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2025-11-24
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.
Conditions
- Severe Aortic Stenosis
Interventions
- DEVICE
-
Navitor 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.
Sponsors & Collaborators
-
Abbott Medical Devices
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-30
- Primary Completion
- 2026-12-31
- Completion
- 2027-03-31
- FDA Device
- Yes
Countries
- Japan
Study Locations
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