Post-Market Clinical Follow Up Study With Navitor Valve

Last updated: February 7, 2025
Sponsor: Abbott Medical Devices
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

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:

  • The patient is scheduled 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:

  • 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

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:
December 31, 2030

Study Description

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

Connect with a study center

  • Clinique du Millénaire

    Montpellier,
    France

    Active - Recruiting

  • Mutualiste Montsouris

    Paris,
    France

    Active - Recruiting

  • CHRU Hopital de Pontchaillou

    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

    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

    Active - Recruiting

  • Medizinische Hochschule Hannover

    Hannover,
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein - Campus Kiel

    Kiel,
    Germany

    Active - Recruiting

  • Medizinische Einrichtungen der Universität zu Köln

    Köln,
    Germany

    Site Not Available

  • Deutsches Herzzentrum München des Freistaates Bayern

    Munchen,
    Germany

    Active - Recruiting

  • University Hospital Rostock

    Rostock,
    Germany

    Active - Recruiting

  • Universitätsklinikum Ulm

    Ulm,
    Germany

    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

    Milano,
    Italy

    Active - Recruiting

  • Ospedale San Raffaele

    Milano,
    Italy

    Active - Recruiting

  • Ospedale San Raffaele - Cardiac

    Milano,
    Italy

    Active - Recruiting

  • Policlinico San Donato

    San Donato Milanese,
    Italy

    Active - Recruiting

  • Policlinico Universitario A. Gemelli

    Trani,
    Italy

    Site Not Available

  • Kokura Memorial Hospital

    Kitakyushu,
    Japan

    Active - Recruiting

  • Osaka Police Hospital

    Osaka-shi, 543-0035
    Japan

    Active - Recruiting

  • Onze Lieve Vrouw Gasthuis

    Amsterdam,
    Netherlands

    Active - Recruiting

  • UMC Utrecht

    Utrecht,
    Netherlands

    Site Not Available

  • Krakowski Szpital Specjalistyczny im. Jana Pawla II

    Kraków,
    Poland

    Site Not Available

  • The Cardinal Stefan Wyszynski Institute of Cardiology

    Warsaw,
    Poland

    Site Not Available

  • Hospital de Santa Cruz

    Carnaxide,
    Portugal

    Active - Recruiting

  • Hospital Universitario de Badajoz

    Badajoz,
    Spain

    Active - Recruiting

  • 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

  • Sahlgrenska University Hospital - Gothenburg

    Gothenburg,
    Sweden

    Active - Recruiting

  • KS St. Gallen / USZ

    Saint Gallen,
    Switzerland

    Active - Recruiting

  • Kings College Hospital

    London,
    United Kingdom

    Active - Recruiting

  • James Cook University Hospital

    Middlesbrough,
    United Kingdom

    Active - Recruiting

  • Royal Stoke University Hospital

    Stoke-on-Trent,
    United Kingdom

    Active - Recruiting

  • New Cross Hospital

    Wolverhampton,
    United Kingdom

    Active - Recruiting

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