Clinical trial NCT06008080: Post-Market Clinical Follow Up Study With Navitor Valve
Official title: VISTA Nova Study (Navitor Post-Market Clinical Follow Up Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Stenosis
Keywords: NAVITOR
Transcatheter aortic valve implantation (TAVI)
Aortic Stenosis
Cardiovascular Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2023-08-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll subjects of all genders from the population of patients qualifying for TAVI.

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.

Eligibility criteria: 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

Primary outcomes:
measure: All-cause mortality at 30 days post-TAVI procedure
timeFrame: 30 days post index procedure
measure: Moderate or greater paravalvular leak at 30 days post-TAVI procedure
timeFrame: 30 days post index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Hobart
country: Australia
facility: Royal Hobart Hospital
city: Montpellier
country: France
facility: Clinique du Millénaire
city: Paris
country: France
facility: Mutualiste Montsouris
city: Rennes
country: France
facility: CHRU Hopital de Pontchaillou
city: Toulouse
country: France
facility: Clinique Pasteur Toulouse
city: Bad Bevensen
country: Germany
facility: Herz- u. Gefäßzentrum Bad Bevensen
city: Berlin
country: Germany
facility: Deutsches Herzzentrum der Charité
city: Dortmund
country: Germany
facility: St Johannes Hospital Dortmund
city: Erlangen
country: Germany
facility: Kliniken der Friedrich-Alexander-Universitat
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
city: Hamburg
country: Germany
facility: UKE Hamburg
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein - Campus Kiel
city: Munchen
country: Germany
facility: Deutsches Herzzentrum München des Freistaates Bayern
city: Rostock
country: Germany
facility: University Hospital Rostock
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Brescia
country: Italy
facility: Az. Osp. Spedali Civili di Brescia
city: Castel Volturno
country: Italy
facility: Casa di Cura Pineta Grande
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Milano
country: Italy
facility: Ospedale San Raffaele - Cardiac
city: San Donato Milanese
country: Italy
facility: Policlinico San Donato
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouw Gasthuis
city: Carnaxide
country: Portugal
facility: ULS de Lisboa Ocidental
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau
city: Huelva
country: Spain
facility: Hospital General Juan Ramon Jimenez
city: Las Palmas
country: Spain
facility: Hospital de Gran Canaria Doctor Negrín
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital - Gothenburg
city: Saint Gallen
country: Switzerland
facility: KS St. Gallen / USZ
city: London
country: United Kingdom
facility: Kings College Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Universitätsmedizin Rostock, Germany
name: Alper Öner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Pasteur Toulouse, France
name: Nicolas Dumonteil, MD
role: PRINCIPAL_INVESTIGATOR
References: