Severe Aortic StenosisNCT07193888
Navitor Japan Study
An observational study of Severe Aortic Stenosis, run by Abbott Medical Devices at 3 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Severe Aortic Stenosis
- What is being tested?
- Navitor Transcatheter Aortic Valve Implantation
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 3 sitesJapan
- Study dates
- 30 Oct 2025to Aug 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic, severe aortic stenosis.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan3 sites, 3 recruiting
- Recruiting
Kokura Memorial Hospital
Fukuoka
Kenji Ando, Dr.
- Recruiting
Shonan Kamakura General Hospital
Kanagawa
Shigeru Saito, Dr.
- Recruiting
Osaka Keisatsu Hospital
Osaka
Yasuhiro Ichibori
About this study
Official title: 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.
Read the 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.
- Conditions
- Severe Aortic Stenosis
- Being tested
- Navitor Transcatheter Aortic Valve Implantation
- Keywords
- NAVITOR, Transcatheter aortic valve implantation (TAVI), Aortic Stenosis, Cardiovascular Disease
- Medical subject headings
- Aortic Valve Stenosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navitor Transcatheter Aortic Valve ImplantationDevice
Also called TAVI
Subjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | This study will enroll subjects of all genders from the population of patients qualifying for TAVI. Receives: Device: Navitor Transcatheter Aortic Valve Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
The primary safety endpoint is all-cause mortality at 30 days post-TAVI procedure, which will be assessed descriptively
Measured: 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.
Measured: 30 days post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start30 Oct 2025
- Primary completionJul 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193888
- Sponsor's protocol ID
- ABT-CIP-10599
- Status last verified
- May 2026
- First submitted
- 19 Sep 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navitor Japan Post-Market Study
- ClinicalTrials.gov ID
- NCT07193888
- Acronym / sponsor ID
- ABT-CIP-10599
- Conditions
- Severe Aortic Stenosis
- Keywords
- NAVITOR, Transcatheter aortic valve implantation (TAVI), Aortic Stenosis, Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Device: Navitor Transcatheter Aortic Valve ImplantationThis study will enroll subjects of all genders from the population of patients qualifying for TAVI. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic, severe aortic stenosis.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navitor Transcatheter Aortic Valve ImplantationAlso: TAVISubjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System. | Device | Cohort 1 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Aortic Stenosis, run by Abbott Medical Devices at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bart Janssens (+32471723201, bart.janssens@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 30 days post index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.