Post-Market Clinical Follow Up Study With Navitor Valve
VISTA Nova
VISTA Nova Study (Navitor Post-Market Clinical Follow Up Study)
1 other identifier
observational
1,000
10 countries
35
Brief Summary
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
Longer than P75 for all trials
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2023
CompletedFirst Posted
Study publicly available on registry
August 23, 2023
CompletedStudy Start
First participant enrolled
September 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2031
June 6, 2025
June 1, 2025
2.9 years
August 16, 2023
June 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
All-cause mortality at 30 days post-TAVI procedure
Death from all causes at 30 days post-TAVI procedure
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
30 days post index procedure
Study Arms (1)
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+.
Interventions
Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System
Eligibility Criteria
This study will enroll subjects of all genders from the population of patients qualifying for TAVI.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alper Öner, MD
Universitätsmedizin Rostock, Germany
- PRINCIPAL INVESTIGATOR
Nicolas Dumonteil, MD
Clinique Pasteur Toulouse, France
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2023
First Posted
August 23, 2023
Study Start
September 29, 2023
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
December 1, 2031
Last Updated
June 6, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share