1,060
Participants
Start Date
January 31, 2016
Primary Completion Date
February 28, 2017
Study Completion Date
February 6, 2020
Medtronic CoreValve™ Evolut R™ System
The Evolut R System is intended for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, to be at high or extreme risk for open heart surgery. The Evolut R TAV treats aortic stenosis by displacing and functionally replacing the dysfunctional native valve with a bioprosthetic valve delivered on a catheter while the heart is still beating, thus avoiding the risks of cardiopulmonary bypass. Its intended performance is to relieve aortic valve stenosis without inducing significant regurgitation, thereby restoring effective aortic valve function.
Flinders Medical Centre, Adelaide
Monash Medical Centre, Melbourne
The Alfred Hospital, Melbourne
Fiona Stanley Hospital Perth, Perth
Universitair Ziekenhuis Antwerpen, Antwerp
London Health Sciences Centre - University Campus, London
Sunnybrook Health Sciences Center, Toronto
Saint Paul's Hospital, Vancouver
Angiografia de Occidente S.A., Santiago de Cali
Nemocnice Podlesi a.s., Třinec
Centre Hospitalier Universitaire - Hopital Henri Mondor, Créteil
Centre Hospitalier Regional Universitaire de Lille, Lille
Institut Hospitalier Jacques Cartier, Massy
Hopital Bichat - Claude Bernard, Paris
Clinique Pasteur, Toulouse
Herz- und Diabeteszentrum NRW - Ruhr-Universitaet Bochum, Bad Oeynhausen
Deutsches Herzzentrum Berlin, Berlin
University of Bonn, Cardiology, Bonn
Sana-Herzzentrum Cottbus GmbH, Cottbus
Herzzentrum Dresden GmbH Universitaetsklinik, Dresden
Universitaetsklinikum Düsseldorf, Düsseldorf
Elisabeth-Krankenhaus Essen GmbH, Essen
Universitätsklinikum Essen, Essen
University of Frankfurt, Frankfurt
Asklepios Klinik Sankt Georg, Hamburg
Städtisches Klinikum Karlsruhe GmbH, Karlsruhe
Herzzentrum Leipzig GmbH, Leipzig
Deutsches Herzzentrum Muenchen - Klinik an der TU Muenchen, Munich
Hygeia Hospital, Athens
Semmelweis Egyetem AOK, Budapest
Tel Aviv Sourasky Medical Center, Tel Aviv
Azienda Ospedaliera Spedali Civili di Brescia, Brescia
Presidio Ospedaliero Ferrarotto Alessi, Catania
IRCCS Policlinico San Donato, Milan
Ospedale San Raffaele - Milano, Milan
Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello, Pisa
Onze Lieve Vrouwe Gasthuis - Locatie Oosterpark, Amsterdam
Catharina Ziekenhuis, Eindhoven
St. Antonius Ziekenhuis, Nieuwegein
Erasmus Medisch Centrum, Rotterdam
Oslo Universitetssykehus-Ullevål Universitetssykehus, Oslo
Complejo Hospitalario Dr Arnulfo Arias Madrid, Panama City
Instytut Kardiologii, Warsaw
Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I, Vila Nova de Gaia
Prince Sultan Cardiac Center, Riyadh
Mediclinic Panorama, Cape Town
Hospital Universitario Virgen de la Victoria, Málaga
Hospital Universitario Central de Asturias, Oviedo
Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela
Akademiska Sjukhuset, Uppsala
Royal Victoria Hospital - Belfast Health and Social Care Trust, Belfast
Royal Sussex County Hospital, Brighton
The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary, Leeds
The Royal Wolverhampton Hospitals NHS - New Cross Hospital, Wolverhampton
Lead Sponsor
Medtronic Cardiovascular
INDUSTRY