Navitor TAVI valve in Japanese patients with severe aortic stenosis

Navitor Japan Post-Market Study

This study will try the Navitor transcatheter aortic valve with the FlexNav delivery system in about 100 Japanese adults with symptomatic severe aortic stenosis to track safety and how well the valve works.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Abbott Medical Devices (Industry-sponsored)
• Locations: 1 site (Osaka)
• Trial ID: NCT07193888 on ClinicalTrials.gov

What this trial studies

This prospective, single-arm, observational multicenter post-market study will enroll approximately 100 Japanese patients with symptomatic severe aortic stenosis who are planned to receive the Navitor TAVI system. All procedures will use the Navitor valve with the FlexNav delivery system and may include future commercially available device iterations as they become available in Japan. Subjects will be followed at hospital discharge, 30 days, and one year after the index procedure to collect safety and performance outcomes in a real-world setting. Eligibility is determined by the treating Heart Team according to the approved device indication and the study uses routine clinical follow-up without randomized controls.

Who should consider this trial

Good fit: Adults in Japan with symptomatic severe aortic stenosis who are judged suitable for Navitor TAVI by their Heart Team, can provide informed consent, and can return for scheduled follow-up visits are ideal candidates.

Not a fit: Patients who are ineligible per the Navitor Instructions for Use, have life expectancy under 12 months from non-cardiac causes, or cannot comply with follow-up are unlikely to benefit from participation.

Why it matters

Potential benefit: If results confirm safety and good valve function, patients could have increased confidence that Navitor TAVI is a safe, less invasive option for treating severe aortic stenosis in Japanese practice.

How similar studies have performed: Other transcatheter aortic valve systems have strong evidence for treating aortic stenosis, and early real-world reports of Navitor show promising safety and performance though long-term, large-scale Japanese data are limited.

Eligibility criteria

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.

Where this trial is running

Osaka

• Osaka Keisatsu Hospital — Osaka, Japan (Recruiting)

Study contacts

• Study coordinator: Bart Janssens

Conditions Severe Aortic Stenosis; NAVITOR; Transcatheter aortic valve implantation; Aortic Stenosis; Cardiovascular Disease