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

June 5, 2025 updated by: Abbott Medical Devices

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Hobart, Australia
        • Recruiting
        • Royal Hobart Hospital
        • Contact:
          • Heath Adams
  • France
      • Montpellier, France
        • Recruiting
        • Clinique du Millénaire
        • Contact:
          • Arnaud Dubar
      • Paris, France
      • Rennes, France
      • Toulouse, France
        • Recruiting
        • Clinique Pasteur Toulouse
        • Contact:
          • Nicolas Dumonteil
  • Germany
      • Bad Bevensen, Germany
        • Recruiting
        • Herz- u. Gefäßzentrum Bad Bevensen
        • Contact:
      • Berlin, Germany
        • Recruiting
        • Deutsches Herzzentrum der Charité
        • Contact:
          • Anna Brand
      • Dortmund, Germany
        • Recruiting
        • St Johannes Hospital Dortmund
        • Contact:
          • Helge Möllmann
      • Erlangen, Germany
        • Recruiting
        • Kliniken der Friedrich-Alexander-Universitat
        • Contact:
      • Frankfurt, Germany
      • Hamburg, Germany
        • Recruiting
        • UKE Hamburg
        • Contact:
          • Andreas Schäfer
      • Kiel, Germany
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein - Campus Kiel
        • Contact:
      • Munchen, Germany
        • Recruiting
        • Deutsches Herzzentrum München des Freistaates Bayern
        • Contact:
      • Rostock, Germany
        • Recruiting
        • University Hospital Rostock
        • Contact:
          • Alper Öner
      • Ulm, Germany
  • Italy
  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • Onze Lieve Vrouw Gasthuis
        • Contact:
  • Portugal
      • Carnaxide, Portugal
        • Recruiting
        • ULS de Lisboa Ocidental
        • Contact:
          • Rui Teles
  • Spain
      • Badajoz, Spain
        • Active, not recruiting
        • Hospital Universitario de Badajoz
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic De Barcelona
        • Contact:
          • Ander Regueiro
      • Barcelona, Spain
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Contact:
          • Lluis Asmarats Serra
      • Huelva, Spain
        • Recruiting
        • Hospital General Juan Ramon Jimenez
        • Contact:
      • Las Palmas, Spain
        • Recruiting
        • Hospital de Gran Canaria Doctor Negrín
        • Contact:
      • Majadahonda, Spain
        • Recruiting
        • Hospital Universitario Puerta de Hierro
        • Contact:
          • Juan Francisco Oteo
      • Valencia, Spain
        • Recruiting
        • Consorcio Hospital General Universitario de Valencia
        • Contact:
          • Dario Sanmiguel Cervera
  • Sweden
      • Gothenburg, Sweden
        • Recruiting
        • Sahlgrenska University Hospital - Gothenburg
        • Contact:
  • Switzerland
      • Saint Gallen, Switzerland
        • Recruiting
        • KS St. Gallen / USZ
        • Contact:
          • Philipp Haager
  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Kings College Hospital
        • Contact:
      • Middlesbrough, United Kingdom
        • Active, not recruiting
        • James Cook University Hospital
      • Stoke-on-Trent, United Kingdom
      • Wolverhampton, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will enroll subjects of all genders from the population of patients qualifying for TAVI.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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+.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality at 30 days post-TAVI procedure
Time Frame: 30 days post index procedure
Death from all causes at 30 days post-TAVI procedure
30 days post index procedure
Moderate or greater paravalvular leak at 30 days post-TAVI procedure
Time Frame: 30 days post index procedure
Assessment of paravalvular leak at 30 days post-TAVI procedure
30 days post index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Alper Öner, MD, Universitätsmedizin Rostock, Germany
  • Principal Investigator: Nicolas Dumonteil, MD, Clinique Pasteur Toulouse, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

August 16, 2023

First Submitted That Met QC Criteria

August 16, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

June 6, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT-CIP-10476

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aortic Stenosis

Clinical Trials on Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe