Post-Market Clinical Follow Up Study With Navitor Valve

Study Overview
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Brief Summary
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Evaluation of the safety and performance of the Navitor TAVI System in a Global Study

Detailed Description
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The VISTA Study will evaluate the safety, performance, and long-term durability of the Navitor valve in a real-world setting.

Official Title
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VISTA Study (Navitor Post-Market Clinical Follow Up Study)

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Device: Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is scheduled 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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System<br>The Navitor valve is available in four valve sizes to cover annulus diameters from 19 mm to 27 mm. The FlexNav delivery system is available in two sizes, small and large. The Navitor loading system is an accessory used to compress and load the Navitor valve onto the FlexNav delivery system and is available in two sizes, small and large. | Device: Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System<br>* Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality at 30 days post-TAVI procedure | Death from all causes at 30 days post-TAVI procedure | 30 days post index procedure | 
| Moderate or greater paravalvular leak at 30 days post-TAVI procedure | Assessment of paravalvular leak at 30 days post-TAVI procedure | 30 days post index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAVITOR, Transcatheter aortic valve implantation (TAVI), Aortic Stenosis, Cardiovascular Disease