Navitor Japan Study

Not yet recruiting

• Conditions: Severe Aortic Stenosis

• Registration Number: NCT07193888
• Lead Sponsor: Abbott Medical Devices

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 Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-19
• Study First Submitted QC: 2025-09-19
• Last Update Submitted: 2025-09-19
• Study First Posted: 2025-09-26
• Last Update Posted: 2025-09-26
• Study Start: 2025-10-01
• Primary Completion: 2026-12
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 at 30 days, as measured by the echocardiographic core laboratory, which will be assessed descriptively