RecruitingNCT06008080
Post-Market Clinical Follow Up Study With Navitor Valve
VISTA Nova Study (Navitor Post-Market Clinical Follow Up Study)
Sponsor
Abbott Medical Devices
Enrollment
1,000 participants
Start Date
Sep 29, 2023
Study Type
OBSERVATIONAL
Conditions
Summary
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
Eligibility
Min Age: 18 YearsMax Age: 100 Years
Inclusion Criteria3
- 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 Criteria7
- 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
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Interventions
DEVICENavitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System
Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System
Locations(35)
View Full Details on ClinicalTrials.gov
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NCT06008080
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