SOURCE XT REGISTRY
- Conditions
- Severe Aortic Stenosis
- Interventions
- Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
- Registration Number
- NCT01238497
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
This registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that are undergoing treatment with the commercially available Edwards SAPIEN XT™ Valve, and delivery devices.
- Detailed Description
Consecutive patient data should be collected at discharge, 30 days and 12 months post-implant. Subsets of patients may undergo additional follow-up.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2954
- The SAPIEN XT™ THV is indicated for use in patients with symptomatic aortic stenosis requiring TAVI who have a high risk for operative mortality, or are "non-operable"
- Non-valvular or congenital aortic stenosis
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Registry 1 - SOURCE XT TAVR Implantation of the Transcatheter Aortic Valve Prosthesis 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) Registry 3 - NovaFlex+ 29 mm TAVR Implantation of the Transcatheter Aortic Valve Prosthesis Registry 3: All patients implanted with a SAPIEN XT valve, 29mm only, via Transfemoral access using NovaFlex+ Registry 2 - Ascendra+ TAVR Implantation of the Transcatheter Aortic Valve Prosthesis Registry 2: All patients implanted with a SAPIEN XT Valve, via Transapical or Transaortic access using Ascendra+ delivery system (23mm, 26mm and 29mm valve)
- Primary Outcome Measures
Name Time Method Assess and track causality and sequelae of major adverse events 30 days
- Secondary Outcome Measures
Name Time Method Effectiveness: observe trends in patient characteristics and outcomes over time One year
Trial Locations
- Locations (103)
Sunninghill Hospital
🇿🇦Johannesburg, Gauteng, South Africa
Vergelegen Medi-Clinic
🇿🇦Somerset West, South Africa
Hospital Universitario Vall Hebron
🇪🇸Barcelona, Spain
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Universitaire Ziekenhuizen Leuven
🇧🇪Leuven, Belgium
Clinique Clairval
🇫🇷Marseille, France
Institut Hospitalier Jacques Cartier
🇫🇷Massy, France
Clinique Saint-Gatien
🇫🇷Tours, France
Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
🇩🇪Bad Krozingen, Germany
Herz- und Diabeteszentrum NRW
🇩🇪Bad Oyenhausen, Germany
Klinikum der Universität München - Großhadern
🇩🇪Munich, Germany
Klinikum Sud Nurnberg
🇩🇪Nurnberg, Germany
Universitatsklinik Wurzburg
🇩🇪Wurzburg, Germany
Panorama Medi-Clinic
🇿🇦Grand Rapids, South Africa
CHU La Cavalle Blanche
🇫🇷Brest, France
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Medical University Vienna
🇦🇹Vienna, Austria
Universitatsklinik Innsbruck
🇦🇹Innsbruck, Austria
Onze Lieve Vrouw Ziekenhuis
🇧🇪Aalst, Belgium
Cliniques Universitaires Saint Luc
🇧🇪Brussels, Belgium
Clinique St Luc
🇧🇪Bouge, Belgium
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
Hamilton Health Services
🇨🇦Hamilton, Ontario, Canada
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
St. John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
Southlake Hospital
🇨🇦Newmarket, Ontario, Canada
Centre Hospitalier De Universite of Montreal
🇨🇦Montreal, Quebec, Canada
Hospital Laval
🇨🇦Sainte-Foy, Quebec, Canada
University of Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Tampere University Hospital
🇫🇮Tampere, Finland
CHU Jean Minjoz
🇫🇷Besançon, 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
Hopital Nord Laënnec
🇫🇷Nantes, France
CHU Montpellier - Hôpital Arnaud de Villeneuve
🇫🇷Montpellier, France
CHU Rangueil
🇫🇷Toulouse, France
Hopital Bichat
🇫🇷Paris, France
CHRU Pontchaillou
🇫🇷Rennes, France
C.H.U Charles Nicolle
🇫🇷Rouen, France
Clinique Pasteur / GCVI
🇫🇷Toulouse, France
Zentralklinik Bad Berka GmbH
🇩🇪Bad Berka, Germany
Kerckhoff Klinik
🇩🇪Bad Nauheim, Germany
Herz- und Gefäss-Klinik GmbH
🇩🇪Bad Neustadt, Germany
Evangelisch Freikirchliches Krankenhaus
🇩🇪Bernau, Germany
Herzzentrum Dresden GmbH Universitätsklinik
🇩🇪Dresden, Germany
Städtisches Klinikum
🇩🇪Dortmund, Germany
Universitätsklinik Erlangen
🇩🇪Erlangen, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
Universitätsklinikum
🇩🇪Köln, Germany
Asklepios Klinik St Georg
🇩🇪Hamburg, Germany
Universitatsmedizin Gottingen
🇩🇪Goettingen, Germany
Universitatsklinikum Eppendorf
🇩🇪Hamburg, Germany
Johannes Gutenberg Universität Mainz
🇩🇪Mainz, Germany
KLINIKUM KARLSBURG der Klinikgruppe Dr. Guth GmbH & Co. KG
🇩🇪Karlsburg, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany
Herzzentrum Leipzig GmbH
🇩🇪Leipzig, Germany
Städtisches Klinikum Karlsruhe
🇩🇪Karlsruhe, Germany
Universitätsklinikum Münster
🇩🇪Muenster, Germany
Klinikum Bogenhausen
🇩🇪Munich, Germany
Deutsches Herzzentrum Muenchen
🇩🇪Munich, Germany
Klinikum Schwabing
🇩🇪Munich, Germany
Universitatsklinikum Regensburg
🇩🇪Regensburg, Germany
SANA Herzzentrum
🇩🇪Stuttgart, Germany
Hygeia Hospital
🇬🇷Athens, Greece
Rambam Medical Center
🇮🇱Haifa, Israel
Shaare Zedek
🇮🇱Jerusalem, Israel
Rabin Medical Center
🇮🇱Petach Tikva, Israel
The Chaim Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Clinica Sant'Anna Hospital
🇮🇹Catanzaro, Italy
Ospedale Pasquinucci
🇮🇹Massa, Italy
Clinica Montevergine
🇮🇹Mercogliano, Italy
Azienda Ospedaliera Policlinico Universitario
🇮🇹Padova, Italy
Ospedale San Raffaele
🇮🇹Milano, Italy
Centro Cardiologico Monzino
🇮🇹Milano, Italy
Hesperia Hospital
🇮🇹Modena, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano Milano, Italy
Maastricht UMC+
🇳🇱Maastricht, Netherlands
Universitetssykehuset Nord-Norge
🇳🇴Tromso, Norway
Ospedale San Giovanni Battista
🇮🇹Torino, Italy
The Cardinal Stefan Wyszyński Institute of Cardiology
🇵🇱Warsaw, Poland
St Augustine's Hospital
🇿🇦Durban, South Africa
UNITAS Hospital
🇿🇦Pretoria, South Africa
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
C.H.U. A Coruña
🇪🇸A Coruña, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Virgen de Arrixaca
🇪🇸Murcia, Spain
Policlinica Gipuzkoa
🇪🇸San Sebastian, Spain
Hospital Marques de Valdecilla
🇪🇸Santander, Spain
Complexo Hospitalario Universitario de Vigo
🇪🇸Vigo, Spain
Hospital Virgen Macarena
🇪🇸Sevilla, Spain
Inselspital Bern
🇨🇭Bern, Switzerland
Klinik im Park
🇨🇭Zurich, Switzerland
London Chest Hospital
🇬🇧London, United Kingdom
King's College Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
St Thomas Hospital
🇬🇧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