Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
The VISTA Nova Study will evaluate the safety, performance, and long-term durability of the Navitor valve in a real-world setting.
Study Type
OBSERVATIONAL
Enrollment
1,000
Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System
All-cause mortality at 30 days post-TAVI procedure
Death from all causes at 30 days post-TAVI procedure
Time frame: 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
Time frame: 30 days post index procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Royal Adelaide Hospital
Adelaide, Australia
RECRUITINGRoyal Hobart Hospital
Hobart, Australia
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Melbourne, Australia
RECRUITINGInstitute Cardio. Paris-Sud - Institut Jacques Cartier
Massy, France
RECRUITINGClinique du Millénaire
Montpellier, France
RECRUITINGMutualiste Montsouris
Paris, France
RECRUITINGCHRU Hopital de Pontchaillou
Rennes, France
RECRUITINGCHU Pointchaillou Rennes
Rennes, France
RECRUITINGClinique Pasteur Toulouse
Toulouse, France
RECRUITINGHerz- u. Gefäßzentrum Bad Bevensen
Bad Bevensen, Germany
RECRUITING...and 40 more locations