Severe Aortic Stenosis
Conditions
Keywords
NAVITOR, Transcatheter aortic valve implantation (TAVI), Aortic Stenosis, Cardiovascular Disease
Brief 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.
Interventions
DEVICENavitor 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
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is eligible per the current approved indication after Heart Team discussion and intended to undergo a Navitor TAVI procedure. 2. 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. 3. The patient and the treating physician agree that the subject will return for all required post-procedure follow-up visits
Exclusion criteria
1. Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU). 2. Life expectancy \< 12 months from the time of informed consent due to non-cardiac co-morbid conditions. 3. 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. 4. Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated. 5. Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be adequately premedicated. 6. Currently participating in an investigational drug or device study that may confound the results of this study. 7. Anatomy that makes insertion and endovascular access to the aortic valve difficult and/or impossible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | 30 days post index procedure | The primary safety endpoint is all-cause mortality at 30 days post-TAVI procedure, which will be assessed descriptively |
| Primary Performance Endpoint | 30 days post index procedure | 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. |
Countries
Japan
Contacts
CONTACTBart Janssens
CONTACTAlicia Kimber
Outcome results
None listed