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Post-Market Clinical Follow Up Study With Navitor Valve
Sponsor: Abbott Medical Devices
Summary
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
Official title: VISTA Nova Study (Navitor Post-Market Clinical Follow Up Study)
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2023-09-29
Completion Date
2031-12
Last Updated
2025-06-06
Healthy Volunteers
No
Conditions
Interventions
Navitor 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)
Royal Hobart Hospital
Hobart, Australia
Clinique du Millénaire
Montpellier, France
Mutualiste Montsouris
Paris, France
CHRU Hopital de Pontchaillou
Rennes, France
Clinique Pasteur Toulouse
Toulouse, France
Herz- u. Gefäßzentrum Bad Bevensen
Bad Bevensen, Germany
Deutsches Herzzentrum der Charité
Berlin, Germany
St Johannes Hospital Dortmund
Dortmund, Germany
Kliniken der Friedrich-Alexander-Universitat
Erlangen, Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt, Germany
UKE Hamburg
Hamburg, Germany
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Germany
Deutsches Herzzentrum München des Freistaates Bayern
München, Germany
University Hospital Rostock
Rostock, Germany
Universitätsklinikum Ulm
Ulm, Germany
Az. Osp. Spedali Civili di Brescia
Brescia, Italy
Casa di Cura Pineta Grande
Castel Volturno, Italy
Centro Cardiologico Monzino
Milan, Italy
Ospedale San Raffaele - Cardiac
Milan, Italy
Policlinico San Donato
San Donato Milanese, Italy
Onze Lieve Vrouw Gasthuis
Amsterdam, Netherlands
ULS de Lisboa Ocidental
Carnaxide, Portugal
Hospital Universitario de Badajoz
Badajoz, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital de la Santa Creu I Sant Pau
Barcelona, Spain
Hospital General Juan Ramon Jimenez
Huelva, Spain
Hospital de Gran Canaria Doctor Negrín
Las Palmas, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, Spain
Sahlgrenska University Hospital - Gothenburg
Gothenburg, Sweden
KS St. Gallen / USZ
Sankt Gallen, Switzerland
Kings College Hospital
London, United Kingdom
James Cook University Hospital
Middlesbrough, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom