Post-Market Clinical Follow Up Study With Navitor Valve

Recruiting now

Conditions studied: Aortic Stenosis

In brief

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

Key facts

Study ID

NCT06008080

Run by

Abbott Medical Devices

People needed

1000

Starts

2023-09-29

Expected to finish

2032-06-01

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• New Cross Hospital — Wolverhampton, United Kingdom (enrolling)
• Royal Hobart Hospital — Hobart, Australia (enrolling)
• The Alfred Hospital — Melbourne, Australia (enrolling)
• Institute Cardio. Paris-Sud - Institut Jacques Cartier — Massy, France (enrolling)
• Clinique du Millénaire — Montpellier, France (enrolling)
• Mutualiste Montsouris — Paris, France (enrolling)
• CHRU Hopital de Pontchaillou — Rennes, France (enrolling)
• CHU Pointchaillou Rennes — Rennes, France (enrolling)
• Clinique Pasteur Toulouse — Toulouse, France (enrolling)
• Herz- u. Gefäßzentrum Bad Bevensen — Bad Bevensen, Germany (enrolling)
• Sahlgrenska University Hospital - Gothenburg — Gothenburg, Sweden (enrolling)
• KS St. Gallen / USZ — Sankt Gallen, Switzerland (enrolling)
• Kings College Hospital — London, United Kingdom (enrolling)
• St. Thomas Hospital — London, United Kingdom (enrolling)
• Royal Stoke University Hospital — Stoke-on-Trent, United Kingdom (enrolling)
• Royal Adelaide Hospital — Adelaide, Australia (enrolling)
• Medizinische Einrichtungen der Universität zu Köln — Cologne, Germany (enrolling)
• St Johannes Hospital Dortmund — Dortmund, Germany (enrolling)
• Kliniken der Friedrich-Alexander-Universitat — Erlangen, Germany (enrolling)
• Klinikum der Johann Wolfgang Goethe-Universität Frankfurt — Frankfurt, Germany (enrolling)
• Universitätsklinikum Schleswig-Holstein - Campus Kiel — Kiel, Germany (enrolling)
• Deutsches Herzzentrum München des Freistaates Bayern — München, Germany (enrolling)
• Universitätsklinikum Ulm — Ulm, Germany (enrolling)
• Sheba Medical Center — Tel Litwinsky, Israel (enrolling)
• Az. Osp. Spedali Civili di Brescia — Brescia, Italy (enrolling)

Full record on ClinicalTrials.gov

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