Post-Market Clinical Follow Up Study With Navitor Valve

Recruiting

• Conditions: Aortic Stenosis
• Interventions: Device: Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System

• Registration Number: NCT06008080
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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.

Study Timeline

• Study First Submitted: 2023-08-16
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-23
• Study Start: 2023-09-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-09
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System	Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System	The Navitor valve is available in four valve sizes to cover annulus diameters from 19 mm to 27 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 large.

Primary Outcome Measures

Name	Time	Method
Moderate or greater paravalvular leak at 30 days post-TAVI procedure	30 days post index procedure	Assessment of paravalvular leak at 30 days post-TAVI procedure
All-cause mortality at 30 days post-TAVI procedure	30 days post index procedure	Death from all causes at 30 days post-TAVI procedure

Trial Locations

Locations (35)

Osaka Police Hospital; 🇯🇵 Osaka-shi, Japan

Clinique du Millénaire; 🇫🇷 Montpellier, France

Mutualiste Montsouris; 🇫🇷 Paris, France

CHRU Hopital de Pontchaillou; 🇫🇷 Rennes, France

Clinique Pasteur Toulouse; 🇫🇷 Toulouse, France

Herz- u. Gefäßzentrum Bad Bevensen; 🇩🇪 Bad Bevensen, Germany

Deutsches Herzzentrum der Charité; 🇩🇪 Berlin, 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; 🇩🇪 Munchen, Germany

University Hospital Rostock; 🇩🇪 Rostock, Germany

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany

Az. Osp. Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

Casa di Cura Pineta Grande; 🇮🇹 Castel Volturno, Italy

Centro Cardiologico Monzino; 🇮🇹 Milano, Italy

Ospedale San Raffaele - Cardiac; 🇮🇹 Milano, Italy

Policlinico San Donato; 🇮🇹 San Donato Milanese, Italy

Kokura Memorial Hospital; 🇯🇵 Kitakyushu, Japan

Onze Lieve Vrouw Gasthuis; 🇳🇱 Amsterdam, Netherlands

Hospital de Santa Cruz; 🇵🇹 Carnaxide, 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

Sahlgrenska University Hospital - Gothenburg; 🇸🇪 Gothenburg, Sweden

KS St. Gallen / USZ; 🇨🇭 Saint Gallen, Switzerland

Kings College Hospital; 🇬🇧 London, United Kingdom

James Cook University Hospital; 🇬🇧 Middlesbrough, United Kingdom

Royal Stoke University Hospital; 🇬🇧 Stoke-on-Trent, United Kingdom

New Cross Hospital; 🇬🇧 Wolverhampton, United Kingdom