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Recruiting NCT06008080

Post-Market Clinical Follow Up Study With Navitor Valve

— Observational Aortic Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System.
Who it may be relevant to
Registry conditions: Aortic Stenosis. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, France, Germany, Israel, Italy +6
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

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

Interventions

  • Device Navitor 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

Primary outcome measures

  • All-cause mortality at 30 days post-TAVI procedure [Time frame: 30 days post index procedure]
  • Moderate or greater paravalvular leak at 30 days post-TAVI procedure [Time frame: 30 days post index procedure]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 11 centers
  • Herz- u. Gefäßzentrum Bad Bevensen — Bad Bevensen
  • Deutsches Herzzentrum der Charité — Berlin
  • Medizinische Einrichtungen der Universität zu Köln — Cologne
  • St Johannes Hospital Dortmund — Dortmund
  • Kliniken der Friedrich-Alexander-Universitat — Erlangen
  • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt — Frankfurt
  • UKE Hamburg — Hamburg
  • Universitätsklinikum Schleswig-Holstein - Campus Kiel — Kiel
  • … and 3 more centers
Italy · 8 centers
  • Az. Osp. Spedali Civili di Brescia — Brescia
  • Casa di Cura Pineta Grande — Castel Volturno
  • Centro Cardiologico Monzino — Milan
  • Ospedale San Raffaele - Cardiac — Milan
  • IRCCS ISMETT - Palermo — Palermo
  • Policlinico Universitario A. Gemelli — Roma
  • Policlinico San Donato — San Donato Milanese
  • Ospedale Umberto I di Torino — Torino
Spain · 8 centers
  • Hospital Universitario de Badajoz — Badajoz
  • Hospital Clinic de Barcelona — Barcelona
  • Hospital de la Santa Creu I Sant Pau — Barcelona
  • Hospital General Juan Ramon Jimenez — Huelva
  • Hospital de Gran Canaria Doctor Negrín — Las Palmas
  • Hospital Universitario Puerta de Hierro — Majadahonda
  • HCU Virgen de la Victoria — Málaga
  • Consorcio Hospital General Universitario de Valencia — Valencia
France · 6 centers
  • Institute Cardio. Paris-Sud - Institut Jacques Cartier — Massy
  • Clinique du Millénaire — Montpellier
  • Mutualiste Montsouris — Paris
  • CHRU Hopital de Pontchaillou — Rennes
  • CHU Pointchaillou Rennes — Rennes
  • Clinique Pasteur Toulouse — Toulouse
United Kingdom · 6 centers
  • Kings College Hospital — London
  • St. Thomas Hospital — London
  • James Cook University Hospital — Middlesbrough
  • Royal Stoke University Hospital — Stoke-on-Trent
  • Royal Stoke University Hospital — Stoke-on-Trent
  • New Cross Hospital — Wolverhampton
Australia · 3 centers
  • Royal Adelaide Hospital — Adelaide
  • Royal Hobart Hospital — Hobart
  • The Alfred Hospital — Melbourne
Netherlands · 3 centers
  • Onze Lieve Vrouw Gasthuis — Amsterdam
  • Leiden University Medical Center — Leiden
  • UMC Utrecht — Utrecht
Portugal · 2 centers
  • ULS de Lisboa Ocidental — Carnaxide
  • ULS de São José — Lisbon
Israel · 1 center
  • Sheba Medical Center — Tel Litwinsky
Sweden · 1 center
  • Sahlgrenska University Hospital - Gothenburg — Gothenburg
Switzerland · 1 center
  • KS St. Gallen / USZ — Sankt Gallen

Identifiers

NCT: NCT06008080 · ABT-CIP-10476

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗