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Recruiting NCT06008080

Post-Market Clinical Follow Up Study With Navitor Valve

Conditions: Aortic Stenosis

Sponsor: Abbott Medical Devices

trial.available_in: БГ
Overview
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
Description
The VISTA Nova Study will evaluate the safety, performance, and long-term durability of the Navitor valve in a real-world setting.
Who can participate
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
Locations 9
Australia (1)
Royal Hobart Hospital
Hobart
France (1)
Clinique du Millénaire
Montpellier
Germany (1)
Herz- u. Gefäßzentrum Bad Bevensen
Bad Bevensen
Christof Burgdorf
Italy (1)
Az. Osp. Spedali Civili di Brescia
Brescia
Netherlands (1)
Onze Lieve Vrouw Gasthuis
Amsterdam
Giovanni Amoroso
Portugal (1)
ULS de Lisboa Ocidental
Carnaxide
Spain (1)
Hospital Universitario de Badajoz
Badajoz
ACTIVE_NOT_RECRUITING
Sweden (1)
Sahlgrenska University Hospital - Gothenburg
Gothenburg
United Kingdom (1)
Kings College Hospital
London
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
100 Years
Healthy volunteers
No
Start date
29.09.2023
Completion date
01.12.2031
Registry ID
NCT06008080
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.