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Evaluation of the Navitor Valve for Aortic Stenosis

VISTA Nova Study (Navitor Post-Market Clinical Follow Up Study)

Abbott Medical Devices · NCT06008080

This study tests how well the Navitor heart valve works and how safe it is for people with aortic stenosis in everyday situations.

Quick facts

Study typeObservational
Enrollment1000 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorAbbott Medical Devices (industry)
Locations35 sites (Hobart and 34 other locations)
Trial IDNCT06008080 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and performance of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System in patients with aortic stenosis in a real-world setting. It aims to assess the long-term durability of the valve and gather data on its effectiveness post-implantation. Patients will be monitored through follow-up visits to ensure comprehensive data collection and analysis of outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with aortic stenosis who are eligible for the Navitor TAVI procedure and can commit to follow-up visits.

Not a fit: Patients who are not eligible for the Navitor TAVI System or have a life expectancy of less than 12 months due to non-cardiac conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of the Navitor valve, potentially improving treatment options for patients with aortic stenosis.

How similar studies have performed: Other studies evaluating TAVI systems have shown promising results, indicating that this approach is supported by previous successful research.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 IRB (Investigational Review Board)/EC (Ethics Committee) 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.

Exclusion Criteria:

* 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

Where this trial is running

Hobart and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Aortic Stenosis, NAVITOR, Transcatheter aortic valve implantation, Cardiovascular Disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.