Aortic StenosisVISTA NovaNCT06008080
Post-Market Clinical Follow Up Study With Navitor Valve
An observational study of Aortic Stenosis, run by Abbott Medical Devices at 50 sites in 11 countries.
Trial summary
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 50 sitesin 11 countries
- Study dates
- 29 Sep 2023to Jun 2032
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll subjects of all genders from the population of patients qualifying for TAVI.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
50 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
50 sites in 11 countries
Germany11 sites, 8 recruiting
- Recruiting
Herz- u. Gefäßzentrum Bad Bevensen
Bad Bevensen
Christof Burgdorf, C.Burgdorf@hgz-bb.de
- Active, not recruiting
Deutsches Herzzentrum der Charité
Berlin
- Recruiting
Medizinische Einrichtungen der Universität zu Köln
Cologne
Elmar Kuhn, Dr
- Recruiting
St Johannes Hospital Dortmund
Dortmund
Helge Möllmann
- Recruiting
Kliniken der Friedrich-Alexander-Universitat
Erlangen
Mohammed Marwan, +4991318535000, mohamed.marwan@uk-erlangen.de
- Recruiting
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt
Phillipp Seppelt, philipp.seppelt@herz-frankfurt.de
- Active, not recruiting
UKE Hamburg
Hamburg
- Recruiting
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel
Mohammed Saad, Mohammed.Saad@uksh.de
- Recruiting
Deutsches Herzzentrum München des Freistaates Bayern
München
Hendrik Ruge, Ruge@dhm.mhn.de
- Active, not recruiting
University Hospital Rostock
Rostock
- Recruiting
Universitätsklinikum Ulm
Ulm
Wolfgang Rottbauer, +49731500450, sekretariat.rottbauer@uniklinik-ulm.de
Italy8 sites, 8 recruiting
- Recruiting
Az. Osp. Spedali Civili di Brescia
Brescia
Marianna Adamo, mariannaadamo@hotmail.com
- Recruiting
Casa di Cura Pineta Grande
Castel Volturno
Nicola Corcione, nicolacorcione72@gmail.com
- Recruiting
Centro Cardiologico Monzino
Milan
Frederico De Marco, federico.demarco@gmail.com
- Recruiting
Ospedale San Raffaele - Cardiac
Milan
Francesco Maisano, maisano.francesco@hsr.it
- Recruiting
IRCCS ISMETT - Palermo
Palermo
Caterina Gandolfo, Dr
- Recruiting
Policlinico Universitario A. Gemelli
Roma
Carlo Trani, Dr
- Recruiting
Policlinico San Donato
San Donato Milanese
Francesco Bedogni, +39.02.52774980, francesco.bedogni@grupposandonato.it
- Recruiting
Ospedale Umberto I di Torino
Torino
Innocenzo Scrocca, Dr
Spain8 sites, 7 recruiting
- Active, not recruiting
Hospital Universitario de Badajoz
Badajoz
- Recruiting
Hospital Clinic de Barcelona
Barcelona
Ander Regueiro
- Recruiting
Hospital de la Santa Creu I Sant Pau
Barcelona
Lluis Asmarats Serra
- Recruiting
Hospital General Juan Ramon Jimenez
Huelva
Antonio Enrique Gomez Menchero, aegmenchero@hotmail.com
- Recruiting
Hospital de Gran Canaria Doctor Negrín
Las Palmas
Pedro Martin Lorenzo, pemarlor@hotmail.com
- Recruiting
Hospital Universitario Puerta de Hierro
Majadahonda
Juan Francisco Oteo
- Recruiting
HCU Virgen de la Victoria
Málaga
Juan Horacio Alonso Briales, Dr
- Recruiting
Consorcio Hospital General Universitario de Valencia
Valencia
Dario Sanmiguel Cervera
France6 sites, 6 recruiting
- Recruiting
Institute Cardio. Paris-Sud - Institut Jacques Cartier
Massy
Philippe Garot, Dr
- Recruiting
Clinique du Millénaire
Montpellier
Arnaud Dubar
- Recruiting
Mutualiste Montsouris
Paris
Khalil Mahmoudi, khalil.mahmoudi@imm.fr
- Recruiting
CHRU Hopital de Pontchaillou
Rennes
Vincent Auffret, vincent.auffret@chu-rennes.fr
- Recruiting
CHU Pointchaillou Rennes
Rennes
Vincent Auffret, Dr
- Recruiting
Clinique Pasteur Toulouse
Toulouse
Nicolas Dumonteil
United Kingdom6 sites, 4 recruiting
- Recruiting
Kings College Hospital
London
Philip MacCarthy, +4402032992944, philip.maccarthy@nhs.net
- Recruiting
St. Thomas Hospital
London
Tiffany Patterson, Dr
- Active, not recruiting
James Cook University Hospital
Middlesbrough
- Recruiting
Royal Stoke University Hospital
Stoke-on-Trent
Karim Ratib, karim.ratib@uhnm.nhs.uk
- Active, not recruiting
Royal Stoke University Hospital
Stoke-on-Trent
- Recruiting
New Cross Hospital
Wolverhampton
Shahzad Munir, shahzad.munir@nhs.net
Australia3 sites, 3 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide
Joseph Montarello, Dr
- Recruiting
Royal Hobart Hospital
Hobart
Heath Adams
- Recruiting
The Alfred Hospital
Melbourne
Antony Walton, Dr
Netherlands3 sites, 3 recruiting
- Recruiting
Onze Lieve Vrouw Gasthuis
Amsterdam
Giovanni Amoroso, G.Amoroso@olvg.nl
- Recruiting
Leiden University Medical Center
Leiden
Frank Van Der Kley, Dr
- Recruiting
UMC Utrecht
Utrecht
Michiel Voskuil, Dr
Portugal2 sites, 2 recruiting
- Recruiting
ULS de Lisboa Ocidental
Carnaxide
Rui Teles
- Recruiting
ULS de São José
Lisbon
Ines Rodrigues, Dr
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Tel Litwinsky
Israel Barbash
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital - Gothenburg
Gothenburg
Oskar Angeras, +46313421000, oskar.angeras@vgregion.se
Switzerland1 site, 1 recruiting
- Recruiting
KS St. Gallen / USZ
Sankt Gallen
Philipp Haager
About this study
Official title: VISTA Nova Study (Navitor Post-Market Clinical Follow Up Study)
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
Read the detailed description
The VISTA Nova Study will evaluate the safety, performance, and long-term durability of the Navitor valve in a real-world setting.
- Conditions
- Aortic Stenosis
- Being tested
- Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System
- Keywords
- NAVITOR, Transcatheter aortic valve implantation (TAVI), Aortic Stenosis, Cardiovascular Disease
- Medical subject headings
- Aortic Valve Stenosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading SystemDevice
Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System
| Study group | Role | What they receive |
|---|---|---|
| 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+. Receives: Device: Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality at 30 days post-TAVI procedure
Death from all causes at 30 days post-TAVI procedure
Measured: 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
Measured: 30 days post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start29 Sep 2023
- Primary completionJul 2027 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alper Öner, MD, Principal investigator, Universitätsmedizin Rostock, GermanyNicolas Dumonteil, MD, Principal investigator, Clinique Pasteur Toulouse, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008080
- Sponsor's protocol ID
- ABT-CIP-10476
- Acronym
- VISTA Nova
- Status last verified
- Jul 2026
- First submitted
- 16 Aug 2023
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No