Post-Market Clinical Follow Up Study With Navitor Valve
NCT ID: NCT06008080
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2023-09-29
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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+.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
100 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Alper Öner, MD
Role: PRINCIPAL_INVESTIGATOR
Universitätsmedizin Rostock, Germany
Nicolas Dumonteil, MD
Role: PRINCIPAL_INVESTIGATOR
Clinique Pasteur Toulouse, France
Locations
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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
UKE Hamburg
Hamburg, , Germany
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, , Germany
Deutsches Herzzentrum München des Freistaates Bayern
München, , 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
Milan, , Italy
Ospedale San Raffaele - Cardiac
Milan, , Italy
Policlinico San Donato
San Donato Milanese, , Italy
Onze Lieve Vrouw Gasthuis
Amsterdam, , Netherlands
ULS de Lisboa Ocidental
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
Consorcio Hospital General Universitario de Valencia
Valencia, , Spain
Sahlgrenska University Hospital - Gothenburg
Gothenburg, , Sweden
KS St. Gallen / USZ
Sankt 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
Countries
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Central Contacts
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Facility Contacts
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Heath Adams
Role: primary
Arnaud Dubar
Role: primary
Nicolas Dumonteil
Role: primary
Anna Brand
Role: primary
Helge Möllmann
Role: primary
Andreas Schäfer
Role: primary
Alper Öner
Role: primary
Rui Teles
Role: primary
Ander Regueiro
Role: primary
Lluis Asmarats Serra
Role: primary
Juan Francisco Oteo
Role: primary
Dario Sanmiguel Cervera
Role: primary
Philipp Haager
Role: primary
Other Identifiers
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ABT-CIP-10476
Identifier Type: -
Identifier Source: org_study_id
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