Phase
Condition
Congestive Heart Failure
Heart Defect
Treatment
Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The patient is scheduled 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 (InvestigationalReview Board)/EC (Ethics Committee) of the respective clinical site.
The patient and the treating physician agree that the subject will return for allrequired post procedure follow up visits.
Exclusion
Exclusion Criteria:
Life expectancy < 12 months from the time of informed consent due to non-cardiacco-morbid conditions.
In the judgment of the Investigator, patient presents with a medical, social, orpsychological condition that could limit the ability or willingness to participatein the study, comply with study required testing and/or follow-up visits or thatcould impact scientific integrity of the study.
Known contraindication for computed tomography (CT) or sensitivity to contrastmedia, which cannot be adequately premedicated.
Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickeland titanium), which cannot be adequately premedicated.
Currently participating in an investigational drug or device study that may confoundthe results of this study
Study Design
Study Description
Connect with a study center
Clinique du Millénaire
Montpellier,
FranceActive - Recruiting
Mutualiste Montsouris
Paris,
FranceActive - Recruiting
CHRU Hopital de Pontchaillou
Rennes,
FranceActive - Recruiting
Clinique Pasteur Toulouse
Toulouse,
FranceActive - Recruiting
Herz- u. Gefäßzentrum Bad Bevensen
Bad Bevensen,
GermanyActive - Recruiting
Deutsches Herzzentrum der Charité
Berlin,
GermanyActive - Recruiting
St Johannes Hospital Dortmund
Dortmund,
GermanyActive - Recruiting
Kliniken der Friedrich-Alexander-Universitat
Erlangen,
GermanyActive - Recruiting
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt,
GermanyActive - Recruiting
UKE Hamburg
Hamburg,
GermanyActive - Recruiting
Medizinische Hochschule Hannover
Hannover,
GermanySite Not Available
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel,
GermanyActive - Recruiting
Medizinische Einrichtungen der Universität zu Köln
Köln,
GermanySite Not Available
Deutsches Herzzentrum München des Freistaates Bayern
Munchen,
GermanyActive - Recruiting
University Hospital Rostock
Rostock,
GermanyActive - Recruiting
Universitätsklinikum Ulm
Ulm,
GermanyActive - Recruiting
Az. Osp. Spedali Civili di Brescia
Brescia,
ItalyActive - Recruiting
Casa di Cura Pineta Grande
Castel Volturno,
ItalyActive - Recruiting
Centro Cardiologico Monzino
Milano,
ItalyActive - Recruiting
Ospedale San Raffaele
Milano,
ItalyActive - Recruiting
Ospedale San Raffaele - Cardiac
Milano,
ItalyActive - Recruiting
Policlinico San Donato
San Donato Milanese,
ItalyActive - Recruiting
Policlinico Universitario A. Gemelli
Trani,
ItalySite Not Available
Kokura Memorial Hospital
Kitakyushu,
JapanActive - Recruiting
Osaka Police Hospital
Osaka-shi, 543-0035
JapanActive - Recruiting
Onze Lieve Vrouw Gasthuis
Amsterdam,
NetherlandsActive - Recruiting
UMC Utrecht
Utrecht,
NetherlandsSite Not Available
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Kraków,
PolandSite Not Available
The Cardinal Stefan Wyszynski Institute of Cardiology
Warsaw,
PolandSite Not Available
Hospital de Santa Cruz
Carnaxide,
PortugalActive - Recruiting
Hospital Universitario de Badajoz
Badajoz,
SpainActive - Recruiting
Hospital Clinic de Barcelona
Barcelona,
SpainActive - Recruiting
Hospital de la Santa Creu I Sant Pau
Barcelona,
SpainActive - Recruiting
Hospital General Juan Ramon Jimenez
Huelva,
SpainActive - Recruiting
Hospital de Gran Canaria Doctor Negrín
Las Palmas,
SpainActive - Recruiting
Hospital Universitario Puerta de Hierro
Majadahonda,
SpainActive - Recruiting
Sahlgrenska University Hospital - Gothenburg
Gothenburg,
SwedenActive - Recruiting
KS St. Gallen / USZ
Saint Gallen,
SwitzerlandActive - Recruiting
Kings College Hospital
London,
United KingdomActive - Recruiting
James Cook University Hospital
Middlesbrough,
United KingdomActive - Recruiting
Royal Stoke University Hospital
Stoke-on-Trent,
United KingdomActive - Recruiting
New Cross Hospital
Wolverhampton,
United KingdomActive - Recruiting
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