Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation

NARecruitingINTERVENTIONAL
Enrollment

590

Participants

Timeline

Start Date

June 13, 2021

Primary Completion Date

June 30, 2025

Study Completion Date

February 28, 2036

Conditions
Symptomatic Severe Aortic Stenosis
Interventions
DEVICE

Navitor Transcatheter Aortic Valve and FlexNav Delivery System

"For traditional application, the Navitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are intermediate or low surgical risk.~For the valve-in-valve application, the Navitor valve is indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve.~Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve and FlexNav Delivery system"

Trial Locations (39)

3015

ACTIVE_NOT_RECRUITING

Erasmus MC - Thoraxcenter, Rotterdam

20097

RECRUITING

Policlinico San Donato, Milan

28034

RECRUITING

Hospital Ramón y Cajal, Madrid

28040

RECRUITING

Hospital Clinico Universitario San Carlos, Madrid

35128

RECRUITING

Azienda Ospedale Università Padova, Padua

81030

RECRUITING

Pineta Grande Hospital, Castel Volturno

9103012

RECRUITING

Shaare Zedek Medical Center, Jerusalem

Unknown

RECRUITING

St. Andrew's Hospital, Adelaide

RECRUITING

The Alfred Hospital, Melbourne

RECRUITING

Macquirie University Hopsital, Ryde

WITHDRAWN

Universitätsklinik Graz, Graz

RECRUITING

Kepler Universitätsklinikum GmbH, Linz

RECRUITING

AKH Wien, Vienna

RECRUITING

Rigshospitalet, Copenhagen

RECRUITING

CHU Gabriel Montpied, Clermont-Ferrand

RECRUITING

Hopital Haut Leveque, Pessac

RECRUITING

Clinique Pasteur Toulouse, Toulouse

RECRUITING

Kerckhoff-Klinik GgmbH, Bad Nauheim

RECRUITING

Universitätsmedizin Berlin - Charité Campus Mitte (CCM), Berlin

RECRUITING

St. Johannes-Hospital, Dortmund

RECRUITING

Herzzentrum Dresden, Dresden

RECRUITING

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt, Frankfurt

RECRUITING

UKE Hamburg (Universitatsklinik Eppendorf), Hamburg

RECRUITING

Herzzentrum Leipzig GmbH, Leipzig

WITHDRAWN

Universität Mainz (Johannes Gutenberg-Universität Mainz), Mainz

RECRUITING

DHZ München, München

RECRUITING

Centro Cardiologico Monzino, Milan

RECRUITING

Ospedale San Raffaele - Cardiac, Milan

RECRUITING

Hospital General Universitario Dr. Balmis, Alicante

RECRUITING

Hospital Clínic de Barcelona, Barcelona

RECRUITING

Hospital Virgen de Rocio, Seville

ACTIVE_NOT_RECRUITING

HerzZentrum Hirslanden, Zurich

RECRUITING

Royal Victoria Hospital, Belfast

RECRUITING

Leeds General Infirmary, Leeds

RECRUITING

Kings College Hospital, London

WA 6150

RECRUITING

Fiona Stanley Hospital, Murdoch

NSW 2031

RECRUITING

Prince of Wales Hospital, Sydney

QLD 4102,

RECRUITING

Princess Alexandra Hospital, Woolloongabba

SA6 6NL

RECRUITING

Morriston Hospital, Swansea

Sponsors
All Listed Sponsors
lead

Abbott Medical Devices

INDUSTRY

NCT04788888 - Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation | Biotech Hunter | Biotech Hunter