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.
Study Type
OBSERVATIONAL
Enrollment
100
Subjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System.
Kokura Memorial Hospital
Fukuoka, Japan
RECRUITINGShonan Kamakura General Hospital
Kanagawa, Japan
RECRUITINGOsaka Keisatsu Hospital
Osaka, Japan
RECRUITINGPrimary 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
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