NCT07193888

Navitor Japan Study

Navitor Japan Post-Market Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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 safety and performance of the Navitor TAVI system, including future commercially available iterations, as they become available in Japan. Enrolled subjects will undergo follow-up at discharge, 30 days and 1-year post-index procedure.

Conditions

• Severe Aortic Stenosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-30
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2025-09-26
• Last updated: 2025-11-24

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated device study