Navitor Japan Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Navitor Transcatheter Aortic Valve Implantation.
- Who it may be relevant to
- Registry conditions: Severe Aortic Stenosis. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Navitor Japan Post-Market Study
Overview
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.
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.
Primary outcome measures
- Primary Safety Endpoint [Time frame: 30 days post index procedure]
- Primary Performance Endpoint [Time frame: 30 days post index procedure]
Eligibility criteria
Inclusion criteria
- Patient is eligible per the current approved indication after Heart Team discussion and intended to undergo a Navitor TAVI procedure.
- The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the EC of the respective clinical site.
- The patient and the treating physician agree that the subject will return for all required post-procedure follow-up visits
Exclusion criteria
- Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU).
- Life expectancy < 12 months from the time of informed consent due to non-cardiac co-morbid conditions.
- In the judgment of the Investigator, patient presents with a medical, social, or psychological condition that could limit the ability or willingness to participate in the study, comply with study required testing and/or follow-up visits or that could impact scientific integrity of the study.
- Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated.
- Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be adequately premedicated.
- Currently participating in an investigational drug or device study that may confound the results of this study.
- Anatomy that makes insertion and endovascular access to the aortic valve difficult and/or impossible.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Japan · 3 centers
- Kokura Memorial Hospital — Fukuoka
- Shonan Kamakura General Hospital — Kanagawa
- Osaka Keisatsu Hospital — Osaka
Identifiers
NCT: NCT07193888 · ABT-CIP-10599