Post-Market Clinical Follow Up Study With Navitor Valve

Recruiting

• Conditions: Aortic Stenosis

• 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: 2025-06
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-06
• 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

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)

Royal Hobart Hospital; 🇦🇺 Hobart, Australia

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

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