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Clinical Trials in the UK / NCT06008080
Recruiting Observational

Post-Market Clinical Follow Up Study With Navitor Valve

NCT06008080 · tracked via the Priya Life Science UK tracker
Sponsor
Abbott Medical Devices
Phase
Observational
Started
2023-09-29
Last updated
2026-07-10

Condition(s) studied

Aortic Stenosis

Investigational drug(s) / intervention(s)

Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (50)

FacilityCityRegionStatus
Royal Adelaide Hospital Adelaide Australia Recruiting
Royal Hobart Hospital Hobart Australia Recruiting
The Alfred Hospital Melbourne Australia Recruiting
Institute Cardio. Paris-Sud - Institut Jacques Cartier Massy France Recruiting
Clinique du Millénaire Montpellier France Recruiting
Mutualiste Montsouris Paris France Recruiting
CHRU Hopital de Pontchaillou Rennes France Recruiting
CHU Pointchaillou Rennes Rennes France Recruiting
Clinique Pasteur Toulouse Toulouse France Recruiting
Herz- u. Gefäßzentrum Bad Bevensen Bad Bevensen Germany Recruiting
Deutsches Herzzentrum der Charité Berlin Germany Active Not Recruiting
Medizinische Einrichtungen der Universität zu Köln Cologne Germany Recruiting
St Johannes Hospital Dortmund Dortmund Germany Recruiting
Kliniken der Friedrich-Alexander-Universitat Erlangen Germany Recruiting
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt Frankfurt Germany Recruiting
UKE Hamburg Hamburg Germany Active Not Recruiting
Universitätsklinikum Schleswig-Holstein - Campus Kiel Kiel Germany Recruiting
Deutsches Herzzentrum München des Freistaates Bayern München Germany Recruiting
University Hospital Rostock Rostock Germany Active Not Recruiting
Universitätsklinikum Ulm Ulm Germany Recruiting
Sheba Medical Center Tel Litwinsky Israel Recruiting
Az. Osp. Spedali Civili di Brescia Brescia Italy Recruiting
Casa di Cura Pineta Grande Castel Volturno Italy Recruiting
Centro Cardiologico Monzino Milan Italy Recruiting
Ospedale San Raffaele - Cardiac Milan Italy Recruiting
IRCCS ISMETT - Palermo Palermo Italy Recruiting
Policlinico Universitario A. Gemelli Roma Italy Recruiting
Policlinico San Donato San Donato Milanese Italy Recruiting
Ospedale Umberto I di Torino Torino Italy Recruiting
Onze Lieve Vrouw Gasthuis Amsterdam Netherlands Recruiting
Leiden University Medical Center Leiden Netherlands Recruiting
UMC Utrecht Utrecht Netherlands Recruiting
ULS de Lisboa Ocidental Carnaxide Portugal Recruiting
ULS de São José Lisbon Portugal Recruiting
Hospital Universitario de Badajoz Badajoz Spain Active Not Recruiting
Hospital Clinic de Barcelona Barcelona Spain Recruiting
Hospital de la Santa Creu I Sant Pau Barcelona Spain Recruiting
Hospital General Juan Ramon Jimenez Huelva Spain Recruiting
Hospital de Gran Canaria Doctor Negrín Las Palmas Spain Recruiting
Hospital Universitario Puerta de Hierro Majadahonda Spain Recruiting

+ 10 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06008080 on ClinicalTrials.gov ↗ ← All trials in the UK