Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2954 participants
OBSERVATIONAL
2010-09-30
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Registry 1 - SOURCE XT
Registry 1: All patients implanted with a SAPIEN XT valve, via Transfemoral access using NovaFlex (for 23mm and 26mm valve), or via Transapical access using Ascendra2 (23mm, 26mm and 29mm valve)
TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Patients eligible for either transfemoral or transapical access and any of the 3 valve sizes (23, 26 or 29)
Registry 2 - Ascendra+
Registry 2: All patients implanted with a SAPIEN XT Valve, via Transapical or Transaortic access using Ascendra+ delivery system (23mm, 26mm and 29mm valve)
TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Patients eligible for transapical or transaortic access and any of the 3 valve sizes (23mm, 26mm or 29mm)
Registry 3 - NovaFlex+ 29 mm
Registry 3: All patients implanted with a SAPIEN XT valve, 29mm only, via Transfemoral access using NovaFlex+
TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Patients eligible for transfemoral access and requiring a 29mm valve.
Interventions
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TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Patients eligible for either transfemoral or transapical access and any of the 3 valve sizes (23, 26 or 29)
TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Patients eligible for transapical or transaortic access and any of the 3 valve sizes (23mm, 26mm or 29mm)
TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Patients eligible for transfemoral access and requiring a 29mm valve.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pre-existing prosthetic heart valve in the Aortic position or a non-calcified aortic valve
* Severe (\>3+) mitral insufficiency or aortic regurgitation \> 3+
* Active bacterial endocarditis or other active infections
* Severe ventricular dysfunction with ejection fraction \< 20%
* Coronary artery disease-related unstable angina
* Inability to tolerate anticoagulation / antiplatelet therapy
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Universitatsklinik Innsbruck
Innsbruck, , Austria
Medical University Vienna
Vienna, , Austria
Onze Lieve Vrouw Ziekenhuis
Aalst, , Belgium
Clinique St Luc
Bouge, , Belgium
Cliniques Universitaires Saint Luc
Brussels, , Belgium
Universitaire Ziekenhuizen Leuven
Leuven, , Belgium
Foothills Medical Centre
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
St. John Regional Hospital
Saint John, New Brunswick, Canada
Hamilton Health Services
Hamilton, Ontario, Canada
Southlake Hospital
Newmarket, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Centre Hospitalier De Universite of Montreal
Montreal, Quebec, Canada
Hospital Laval
Sainte-Foy, Quebec, Canada
University of Hradec Kralove
Hradec Králové, , Czechia
Aarhus University Hospital
Aarhus, , Denmark
Helsinki University Central Hospital
Helsinki, , Finland
Tampere University Hospital
Tampere, , Finland
CHU Jean Minjoz
Besançon, , France
CHU La Cavalle Blanche
Brest, , France
Hôpital Privé Parly II
Le Chesnay, , France
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, , France
CHU La Timone
Marseille, , France
Hôpital St Joseph
Marseille, , France
Clinique Clairval
Marseille, , France
Institut Hospitalier Jacques Cartier
Massy, , France
CHU Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, , France
Hopital Nord Laënnec
Nantes, , France
Hopital Bichat
Paris, , France
CHRU Pontchaillou
Rennes, , France
C.H.U Charles Nicolle
Rouen, , France
CHU Rangueil
Toulouse, , France
Clinique Pasteur / GCVI
Toulouse, , France
Clinique Saint-Gatien
Tours, , France
Zentralklinik Bad Berka GmbH
Bad Berka, , Germany
Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
Bad Krozingen, , Germany
Kerckhoff Klinik
Bad Nauheim, , Germany
Herz- und Gefäss-Klinik GmbH
Bad Neustadt an der Saale, , Germany
Herz- und Diabeteszentrum NRW
Bad Oyenhausen, , Germany
Evangelisch Freikirchliches Krankenhaus
Bernau, , Germany
Universitätsklinikum
Cologne, , Germany
Städtisches Klinikum
Dortmund, , Germany
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, , Germany
Universitätsklinik Erlangen
Erlangen, , Germany
Universitätsklinikum Essen
Essen, , Germany
Universitatsmedizin Gottingen
Göttingen, , Germany
Asklepios Klinik St Georg
Hamburg, , Germany
Universitatsklinikum Eppendorf
Hamburg, , Germany
Universitätsklinikum
Jena, , Germany
KLINIKUM KARLSBURG der Klinikgruppe Dr. Guth GmbH & Co. KG
Karlsburg, , Germany
Städtisches Klinikum Karlsruhe
Karlsruhe, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, , Germany
Herzzentrum Leipzig GmbH
Leipzig, , Germany
Johannes Gutenberg Universität Mainz
Mainz, , Germany
Deutsches Herzzentrum Muenchen
Munich, , Germany
Klinikum Schwabing
Munich, , Germany
Klinikum der Universität München - Großhadern
Munich, , Germany
Klinikum Bogenhausen
Munich, , Germany
Universitätsklinikum Münster
Münster, , Germany
Klinikum Sud Nurnberg
Nuremberg, , Germany
Universitatsklinikum Regensburg
Regensburg, , Germany
SANA Herzzentrum
Stuttgart, , Germany
Universitatsklinik Wurzburg
Würzburg, , Germany
Hygeia Hospital
Athens, , Greece
Rambam Medical Center
Haifa, , Israel
Shaare Zedek
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
The Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Clinica Sant'Anna Hospital
Catanzaro, , Italy
Ospedale Pasquinucci
Massa, , Italy
Clinica Montevergine
Mercogliano, , Italy
Ospedale San Raffaele
Milan, , Italy
Centro Cardiologico Monzino
Milan, , Italy
Hesperia Hospital
Modena, , Italy
Azienda Ospedaliera Policlinico Universitario
Padua, , Italy
Istituto Clinico Humanitas
Rozzano Milano, , Italy
Ospedale San Giovanni Battista
Torino, , Italy
Maastricht UMC+
Maastricht, , Netherlands
Universitetssykehuset Nord-Norge
Tromsø, , Norway
The Cardinal Stefan Wyszyński Institute of Cardiology
Warsaw, , Poland
Sunninghill Hospital
Johannesburg, Gauteng, South Africa
St Augustine's Hospital
Durban, , South Africa
Panorama Medi-Clinic
Grand Rapids, , South Africa
UNITAS Hospital
Pretoria, , South Africa
Vergelegen Medi-Clinic
Somerset West, , South Africa
C.H.U. A Coruña
A Coruña, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Vall Hebron
Barcelona, , Spain
Policlinica Gipuzkoa
Donostia / San Sebastian, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Hospital Virgen de Arrixaca
Murcia, , Spain
Hospital Marques de Valdecilla
Santander, , Spain
Hospital Virgen Macarena
Seville, , Spain
Complexo Hospitalario Universitario de Vigo
Vigo, , Spain
Inselspital Bern
Bern, , Switzerland
Klinik im Park
Zurich, , Switzerland
London Chest Hospital
London, , United Kingdom
St Thomas Hospital
London, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
St Mary's Hospital - Imperial College Healthcare NHS Trust, Hammersmith Hospital . Du Cane Road
London, , United Kingdom
The James Cook University Hospital
Middlesbrough, , United Kingdom
Countries
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References
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Schymik G, Lefevre T, Bartorelli AL, Rubino P, Treede H, Walther T, Baumgartner H, Windecker S, Wendler O, Urban P, Mandinov L, Thomas M, Vahanian A. European experience with the second-generation Edwards SAPIEN XT transcatheter heart valve in patients with severe aortic stenosis: 1-year outcomes from the SOURCE XT Registry. JACC Cardiovasc Interv. 2015 Apr 27;8(5):657-69. doi: 10.1016/j.jcin.2014.10.026.
Other Identifiers
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2010-10
Identifier Type: -
Identifier Source: org_study_id
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