VISTA Nova Study (Navitor Post-Market Clinical Follow Up Study)
Status: Recruiting
Location: See all (35) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Australia
Royal Hobart Hospital
RECRUITING
Hobart
France
Clinique du Millénaire
RECRUITING
Montpellier
Mutualiste Montsouris
RECRUITING
Paris
CHRU Hopital de Pontchaillou
RECRUITING
Rennes
Clinique Pasteur Toulouse
RECRUITING
Toulouse
Germany
Herz- u. Gefäßzentrum Bad Bevensen
RECRUITING
Bad Bevensen
Deutsches Herzzentrum der Charité
RECRUITING
Berlin
St Johannes Hospital Dortmund
RECRUITING
Dortmund
Kliniken der Friedrich-Alexander-Universitat
RECRUITING
Erlangen
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
RECRUITING
Frankfurt
UKE Hamburg
RECRUITING
Hamburg
Universitätsklinikum Schleswig-Holstein - Campus Kiel
RECRUITING
Kiel
Deutsches Herzzentrum München des Freistaates Bayern
RECRUITING
München
University Hospital Rostock
RECRUITING
Rostock
Universitätsklinikum Ulm
RECRUITING
Ulm
Italy
Az. Osp. Spedali Civili di Brescia
RECRUITING
Brescia
Casa di Cura Pineta Grande
RECRUITING
Castel Volturno
Centro Cardiologico Monzino
RECRUITING
Milan
Ospedale San Raffaele - Cardiac
RECRUITING
Milan
Policlinico San Donato
RECRUITING
San Donato Milanese
Netherlands
Onze Lieve Vrouw Gasthuis
RECRUITING
Amsterdam
Portugal
ULS de Lisboa Ocidental
RECRUITING
Carnaxide
Spain
Hospital Universitario de Badajoz
ACTIVE_NOT_RECRUITING
Badajoz
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital de la Santa Creu I Sant Pau
RECRUITING
Barcelona
Hospital General Juan Ramon Jimenez
RECRUITING
Huelva
Hospital de Gran Canaria Doctor Negrín
RECRUITING
Las Palmas
Hospital Universitario Puerta de Hierro
RECRUITING
Majadahonda
Consorcio Hospital General Universitario de Valencia
RECRUITING
Valencia
Sweden
Sahlgrenska University Hospital - Gothenburg
RECRUITING
Gothenburg
Switzerland
KS St. Gallen / USZ
RECRUITING
Sankt Gallen
United Kingdom
Kings College Hospital
RECRUITING
London
James Cook University Hospital
ACTIVE_NOT_RECRUITING
Middlesbrough
Royal Stoke University Hospital
RECRUITING
Stoke-on-trent
New Cross Hospital
RECRUITING
Wolverhampton
Contact Information
Primary
Bart Janssens
bart.janssens@abbott.com
+32471723201
Backup
Alicia Kimber
alicia.kimber@abbott.com
+1 415-917-9696
Time Frame
Start Date: 2023-09-29
Estimated Completion Date: 2031-12
Participants
Target number of participants: 1000
Treatments
Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System
The Navitor valve is available in five valve sizes to cover annulus diameters from 19 mm to 30 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 LG+.
Related Therapeutic Areas
Sponsors
Leads: Abbott Medical Devices