Navitor Japan Post-Market Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Abbott Medical Devices
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Primary Safety Endpoint
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Primary Safety Endpoint
Time Frame: 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
Time Frame: 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.
Primary Safety Endpoint
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported