Status:
RECRUITING
Post-Market Clinical Follow Up Study With Navitor Valve
Lead Sponsor:
Abbott Medical Devices
Conditions:
Aortic Stenosis
Eligibility:
All Genders
18-100 years
Brief Summary
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
Detailed Description
The VISTA Nova Study will evaluate the safety, performance, and long-term durability of the Navitor valve in a real-world setting.
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
September 29 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06008080
Start Date
September 29 2023
End Date
December 1 2031
Last Update
June 6 2025
Active Locations (35)
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1
Royal Hobart Hospital
Hobart, Australia
2
Clinique du Millénaire
Montpellier, France
3
Mutualiste Montsouris
Paris, France
4
CHRU Hopital de Pontchaillou
Rennes, France