Post-Market Clinical Follow Up Study With Navitor Valve

Last updated: July 9, 2026
Sponsor: Abbott Medical Devices
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Vascular Diseases

Heart Defect

Treatment

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

Clinical Study ID

NCT06008080
ABT-CIP-10476
  • Ages 18-100
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient is eligible per the current approved indication after Heart Team discussionand 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 (InvestigationalReview Board)/EC (Ethics Committee) of the respective clinical site.

  • The patient and the treating physician agree that the subject will return for allrequired post procedure follow up visits.

Exclusion

Exclusion Criteria:

  • Patient is not eligible for the Navitor TAVI System per the current Instructions forUse (IFU)

  • Life expectancy < 12 months from the time of informed consent due to non-cardiacco-morbid conditions.

  • In the judgment of the Investigator, patient presents with a medical, social, orpsychological condition that could limit the ability or willingness to participatein the study, comply with study required testing and/or follow-up visits or thatcould impact scientific integrity of the study.

  • Known contraindication for computed tomography (CT) or sensitivity to contrastmedia, which cannot be adequately premedicated.

  • Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickeland titanium), which cannot be adequately premedicated.

  • Currently participating in an investigational drug or device study that may confoundthe results of this study

  • Anatomy that makes insertion and endovascular access to the aortic valve difficultand/or impossible

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System
Phase:
Study Start date:
September 29, 2023
Estimated Completion Date:
June 30, 2032

Study Description

The VISTA Nova Study will evaluate the safety, performance, and long-term durability of the Navitor valve in a real-world setting.

Connect with a study center

  • Royal Adelaide Hospital

    Adelaide,
    Australia

    Active - Recruiting

  • Royal Hobart Hospital

    Hobart,
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne,
    Australia

    Active - Recruiting

  • Institute Cardio. Paris-Sud - Institut Jacques Cartier

    Massy,
    France

    Active - Recruiting

  • Clinique du Millénaire

    Montpellier,
    France

    Active - Recruiting

  • Mutualiste Montsouris

    Paris,
    France

    Active - Recruiting

  • CHRU Hopital de Pontchaillou

    Rennes,
    France

    Active - Recruiting

  • CHU Pointchaillou Rennes

    Rennes,
    France

    Active - Recruiting

  • Clinique Pasteur Toulouse

    Toulouse,
    France

    Active - Recruiting

  • Herz- u. Gefäßzentrum Bad Bevensen

    Bad Bevensen,
    Germany

    Active - Recruiting

  • Deutsches Herzzentrum der Charité

    Berlin,
    Germany

    Site Not Available

  • Medizinische Einrichtungen der Universität zu Köln

    Cologne,
    Germany

    Active - Recruiting

  • St Johannes Hospital Dortmund

    Dortmund,
    Germany

    Active - Recruiting

  • Kliniken der Friedrich-Alexander-Universitat

    Erlangen,
    Germany

    Active - Recruiting

  • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

    Frankfurt,
    Germany

    Active - Recruiting

  • UKE Hamburg

    Hamburg,
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein - Campus Kiel

    Kiel,
    Germany

    Active - Recruiting

  • Deutsches Herzzentrum München des Freistaates Bayern

    München,
    Germany

    Active - Recruiting

  • University Hospital Rostock

    Rostock,
    Germany

    Site Not Available

  • Universitätsklinikum Ulm

    Ulm,
    Germany

    Active - Recruiting

  • Sheba Medical Center

    Tel Litwinsky,
    Israel

    Active - Recruiting

  • Az. Osp. Spedali Civili di Brescia

    Brescia,
    Italy

    Active - Recruiting

  • Casa di Cura Pineta Grande

    Castel Volturno,
    Italy

    Active - Recruiting

  • Centro Cardiologico Monzino

    Milan,
    Italy

    Active - Recruiting

  • Ospedale San Raffaele - Cardiac

    Milan,
    Italy

    Active - Recruiting

  • Centro Cardiologico Monzino

    Milano,
    Italy

    Active - Recruiting

  • Ospedale San Raffaele

    Milano,
    Italy

    Active - Recruiting

  • IRCCS ISMETT - Palermo

    Palermo,
    Italy

    Active - Recruiting

  • Policlinico Universitario A. Gemelli

    Roma,
    Italy

    Active - Recruiting

  • Policlinico San Donato

    San Donato Milanese,
    Italy

    Active - Recruiting

  • Ospedale Umberto I di Torino

    Torino,
    Italy

    Active - Recruiting

  • Onze Lieve Vrouw Gasthuis

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Leiden University Medical Center

    Leiden,
    Netherlands

    Active - Recruiting

  • UMC Utrecht

    Utrecht,
    Netherlands

    Active - Recruiting

  • Hospital de Santa Cruz

    Carnaxide,
    Portugal

    Active - Recruiting

  • ULS de Lisboa Ocidental

    Carnaxide,
    Portugal

    Active - Recruiting

  • ULS de São José

    Lisbon,
    Portugal

    Active - Recruiting

  • Hospital Universitario de Badajoz

    Badajoz,
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu I Sant Pau

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital General Juan Ramon Jimenez

    Huelva,
    Spain

    Active - Recruiting

  • Hospital de Gran Canaria Doctor Negrín

    Las Palmas,
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro

    Majadahonda,
    Spain

    Active - Recruiting

  • HCU Virgen de la Victoria

    Málaga,
    Spain

    Active - Recruiting

  • Consorcio Hospital General Universitario de Valencia

    Valencia,
    Spain

    Active - Recruiting

  • Sahlgrenska University Hospital - Gothenburg

    Gothenburg,
    Sweden

    Active - Recruiting

  • KS St. Gallen / USZ

    Sankt Gallen,
    Switzerland

    Active - Recruiting

  • Kings College Hospital

    London,
    United Kingdom

    Active - Recruiting

  • St. Thomas Hospital

    London,
    United Kingdom

    Active - Recruiting

  • James Cook University Hospital

    Middlesbrough,
    United Kingdom

    Site Not Available

  • Royal Stoke University Hospital

    Stoke-on-Trent,
    United Kingdom

    Active - Recruiting

  • New Cross Hospital

    Wolverhampton,
    United Kingdom

    Active - Recruiting

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