Navitor Japan Study

NCT07193888 | Recruiting FDA Device

• 1 other identifier: ABT-CIP-10599
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Severe Aortic Stenosis

Keywords

NAVITOR; Transcatheter aortic valve implantation (TAVI); Aortic Stenosis; Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

  The primary safety endpoint is all-cause mortality at 30 days post-TAVI procedure, which will be assessed descriptively

  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.

  30 days post index procedure

Study Arms (1)

Cohort 1

This study will enroll subjects of all genders from the population of patients qualifying for TAVI.

Device: Navitor Transcatheter Aortic Valve Implantation

Interventions

Navitor Transcatheter Aortic Valve Implantation DEVICE

Subjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System.

Also known as: TAVI

Cohort 1

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic, severe aortic stenosis.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (3)

Kokura Memorial Hospital

Fukuoka, Japan

RECRUITING

Shonan Kamakura General Hospital

Kanagawa, Japan

RECRUITING

Osaka Keisatsu Hospital

Osaka, Japan

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Bart Janssens

CONTACT

+32471723201; bart.janssens@abbott.com

Alicia Kimber

CONTACT

+1 415-917-9696; alicia.kimber@abbott.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 26, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (3)