RecruitingNCT06008080

Post-Market Clinical Follow Up Study With Navitor Valve

VISTA Nova Study (Navitor Post-Market Clinical Follow Up Study)

Sponsor

Abbott Medical Devices

Enrollment

1,000 participants

Start Date

Sep 29, 2023

Study Type

OBSERVATIONAL

Conditions

Aortic Stenosis

Summary

Evaluation of the safety and performance of the Navitor TAVI System in a Global Study

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System for people with aortic stenosis. The study is currently recruiting participants at 35 locations. People eligible for this study include aged 18 Years to 100 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENavitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System

Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System

Locations(50)

Royal Adelaide Hospital

Adelaide, Australia

Royal Hobart Hospital

Hobart, Australia

The Alfred Hospital

Melbourne, Australia

Institute Cardio. Paris-Sud - Institut Jacques Cartier

Massy, France

Clinique du Millénaire

Montpellier, France

Mutualiste Montsouris

Paris, France

CHRU Hopital de Pontchaillou

Rennes, France

CHU Pointchaillou Rennes

Rennes, France

Clinique Pasteur Toulouse

Toulouse, France

Herz- u. Gefäßzentrum Bad Bevensen

Bad Bevensen, Germany

Deutsches Herzzentrum der Charité

Berlin, Germany

Medizinische Einrichtungen der Universität zu Köln

Cologne, 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

Sheba Medical Center

Tel Litwinsky, Israel

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

IRCCS ISMETT - Palermo

Palermo, Italy

Policlinico Universitario A. Gemelli

Roma, Italy

Policlinico San Donato

San Donato Milanese, Italy

Ospedale Umberto I di Torino

Torino, Italy

Onze Lieve Vrouw Gasthuis

Amsterdam, Netherlands

Leiden University Medical Center

Leiden, Netherlands

UMC Utrecht

Utrecht, Netherlands

ULS de Lisboa Ocidental

Carnaxide, Portugal

ULS de São José

Lisbon, 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

HCU Virgen de la Victoria

Málaga, 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

St. Thomas Hospital

London, United Kingdom

James Cook University Hospital

Middlesbrough, United Kingdom

Royal Stoke University Hospital

Stoke-on-Trent, United Kingdom

Royal Stoke University Hospital

Stoke-on-Trent, United Kingdom

New Cross Hospital

Wolverhampton, United Kingdom

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NCT06008080

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