Aortic Stenosis
Conditions
Keywords
NAVITOR, Transcatheter aortic valve implantation (TAVI), Aortic Stenosis, Cardiovascular Disease
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.
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
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality at 30 days post-TAVI procedure | 30 days post index procedure | Death from all causes at 30 days post-TAVI procedure |
| Moderate or greater paravalvular leak at 30 days post-TAVI procedure | 30 days post index procedure | Assessment of paravalvular leak at 30 days post-TAVI procedure |
Countries
Australia, France, Germany, Israel, Italy, Netherlands, Portugal, Spain, Sweden, Switzerland, United Kingdom
Contacts
CONTACTBart Janssens
CONTACTAlicia Kimber
PRINCIPAL_INVESTIGATORAlper Öner, MD
Universitätsmedizin Rostock, Germany
PRINCIPAL_INVESTIGATORNicolas Dumonteil, MD
Clinique Pasteur Toulouse, France
Outcome results
None listed