Navitor Japan Study

Navitor Japan Post-Market Study

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.

Study Overview

• Status: Recruiting
• Conditions: Severe Aortic Stenosis
• Intervention / Treatment: Device: Navitor Transcatheter Aortic Valve Implantation

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Bart Janssens; Phone Number: +32471723201; Email: bart.janssens@abbott.com
• Study Contact Backup: Name: Alicia Kimber; Phone Number: +1 415-917-9696; Email: alicia.kimber@abbott.com

Study Locations

• Japan
  • Fukuoka, Japan
    • Recruiting
    • Kokura Memorial Hospital
    • Contact: Kenji Ando, Dr.
  • Kanagawa, Japan
    • Recruiting
    • Shonan Kamakura General Hospital
    • Contact: Shigeru Saito, Dr.
  • Osaka, Japan
    • Recruiting
    • Osaka Keisatsu Hospital
    • Contact: Yasuhiro Ichibori

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic, severe aortic stenosis.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; This study will enroll subjects of all genders from the population of patients qualifying for TAVI.	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.; Other Names: TAVI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: September 19, 2025
• First Submitted That Met QC Criteria: September 19, 2025
• First Posted (Actual): September 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cardiovascular Disease; Aortic Stenosis; Transcatheter aortic valve implantation (TAVI); NAVITOR
• Additional Relevant MeSH Terms: Aortic Valve Disease; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Cardiovascular Diseases
• Other Study ID Numbers: ABT-CIP-10599

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes