Post-Market Clinical Follow Up Study With Navitor Valve
Key facts
- Where
- Amsterdam, Leiden, and Utrecht, NetherlandsSee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT06008080, who can take part
Where in Netherlands
- Onze Lieve Vrouw GasthuisAmsterdam, NetherlandsContact: Giovanni AmorosoTaking people
- Leiden University Medical CenterLeiden, NetherlandsContact: Frank Van Der Kley, DrTaking people
- UMC UtrechtUtrecht, NetherlandsContact: Michiel Voskuil, DrTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Abbott Medical Devices
- Trial code
- NCT06008080
- Record updated
- 10 July 2026
- Original description
Evaluation of the safety and performance of the Navitor TAVI System in a Global StudyRead full original descriptionShow less
VISTA Nova Study (Navitor Post-Market Clinical Follow Up Study)
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
Inclusion: 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: 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; 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; Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU); Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated; Anatomy that makes insertion and endovascular access to the aortic valve difficult and/or impossible.