An observational study in Severe Aortic Stenosis, sponsored by Abbott Medical Devices. Recruiting at 3 sites in Japan. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Abbott Medical Devices · Observational
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.
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.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with symptomatic, severe aortic stenosis.
Exclusion Criteria:
This study will enroll subjects of all genders from the population of patients qualifying for TAVI.
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.
Also known as: TAVI
Primary Safety Endpoint
The primary safety endpoint is all-cause mortality at 30 days post-TAVI procedure, which will be assessed descriptively
Time frame: 30 days post index procedure
Primary Performance Endpoint
The primary performance endpoint is moderate or greater paravalvular leak (PVL) at 30 days as measured on a transthoracic echocardiogram (TTE) by the echocardiographic core laboratory. This endpoint will be reported as % subjects with moderate or greater PVL at 30 days.
Time frame: 30 days post index procedure
Plan to share: No
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