Phase
Condition
Congestive Heart Failure
Vascular Diseases
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:
Patient is eligible per the current approved indication after Heart Team discussionand 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 (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:
Patient is not eligible for the Navitor TAVI System per the current Instructions forUse (IFU)
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
Anatomy that makes insertion and endovascular access to the aortic valve difficultand/or impossible
Study Design
Study Description
Connect with a study center
Royal Adelaide Hospital
Adelaide,
AustraliaActive - Recruiting
Royal Hobart Hospital
Hobart,
AustraliaActive - Recruiting
The Alfred Hospital
Melbourne,
AustraliaActive - Recruiting
Institute Cardio. Paris-Sud - Institut Jacques Cartier
Massy,
FranceActive - Recruiting
Clinique du Millénaire
Montpellier,
FranceActive - Recruiting
Mutualiste Montsouris
Paris,
FranceActive - Recruiting
CHRU Hopital de Pontchaillou
Rennes,
FranceActive - Recruiting
CHU Pointchaillou Rennes
Rennes,
FranceActive - Recruiting
Clinique Pasteur Toulouse
Toulouse,
FranceActive - Recruiting
Herz- u. Gefäßzentrum Bad Bevensen
Bad Bevensen,
GermanyActive - Recruiting
Deutsches Herzzentrum der Charité
Berlin,
GermanySite Not Available
Medizinische Einrichtungen der Universität zu Köln
Cologne,
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,
GermanySite Not Available
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel,
GermanyActive - Recruiting
Deutsches Herzzentrum München des Freistaates Bayern
München,
GermanyActive - Recruiting
University Hospital Rostock
Rostock,
GermanySite Not Available
Universitätsklinikum Ulm
Ulm,
GermanyActive - Recruiting
Sheba Medical Center
Tel Litwinsky,
IsraelActive - Recruiting
Az. Osp. Spedali Civili di Brescia
Brescia,
ItalyActive - Recruiting
Casa di Cura Pineta Grande
Castel Volturno,
ItalyActive - Recruiting
Centro Cardiologico Monzino
Milan,
ItalyActive - Recruiting
Ospedale San Raffaele - Cardiac
Milan,
ItalyActive - Recruiting
Centro Cardiologico Monzino
Milano,
ItalyActive - Recruiting
Ospedale San Raffaele
Milano,
ItalyActive - Recruiting
IRCCS ISMETT - Palermo
Palermo,
ItalyActive - Recruiting
Policlinico Universitario A. Gemelli
Roma,
ItalyActive - Recruiting
Policlinico San Donato
San Donato Milanese,
ItalyActive - Recruiting
Ospedale Umberto I di Torino
Torino,
ItalyActive - Recruiting
Onze Lieve Vrouw Gasthuis
Amsterdam,
NetherlandsActive - Recruiting
Leiden University Medical Center
Leiden,
NetherlandsActive - Recruiting
UMC Utrecht
Utrecht,
NetherlandsActive - Recruiting
Hospital de Santa Cruz
Carnaxide,
PortugalActive - Recruiting
ULS de Lisboa Ocidental
Carnaxide,
PortugalActive - Recruiting
ULS de São José
Lisbon,
PortugalActive - Recruiting
Hospital Universitario de Badajoz
Badajoz,
SpainSite Not Available
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
HCU Virgen de la Victoria
Málaga,
SpainActive - Recruiting
Consorcio Hospital General Universitario de Valencia
Valencia,
SpainActive - Recruiting
Sahlgrenska University Hospital - Gothenburg
Gothenburg,
SwedenActive - Recruiting
KS St. Gallen / USZ
Sankt Gallen,
SwitzerlandActive - Recruiting
Kings College Hospital
London,
United KingdomActive - Recruiting
St. Thomas Hospital
London,
United KingdomActive - Recruiting
James Cook University Hospital
Middlesbrough,
United KingdomSite Not Available
Royal Stoke University Hospital
Stoke-on-Trent,
United KingdomActive - Recruiting
New Cross Hospital
Wolverhampton,
United KingdomActive - Recruiting

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