SOURCE XT REGISTRY
Edwards SAPIEN™ Aortic Bioprosthesis Multi-Region Outcome Registry XT
1 other identifier
observational
2,954
18 countries
104
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2010
Longer than P75 for all trials
104 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 26, 2010
CompletedFirst Posted
Study publicly available on registry
November 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedAugust 28, 2020
August 1, 2020
3.9 years
October 26, 2010
August 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess and track causality and sequelae of major adverse events
30 days
Secondary Outcomes (1)
Effectiveness: observe trends in patient characteristics and outcomes over time
One year
Study Arms (3)
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)
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)
Registry 3 - NovaFlex+ 29 mm
Registry 3: All patients implanted with a SAPIEN XT valve, 29mm only, via Transfemoral access using NovaFlex+
Interventions
Patients eligible for either transfemoral or transapical access and any of the 3 valve sizes (23, 26 or 29)
Eligibility Criteria
Patients with symptomatic aortic stenosis
You may qualify if:
- 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"
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (104)
Universitatsklinik Innsbruck
Innsbruck, 6020, Austria
Medical University Vienna
Vienna, 1090, Austria
Onze Lieve Vrouw Ziekenhuis
Aalst, 9300, Belgium
Clinique St Luc
Bouge, 5004, Belgium
Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
Universitaire Ziekenhuizen Leuven
Leuven, 3000, Belgium
Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
St. John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Hamilton Health Services
Hamilton, Ontario, L8L 2X2, Canada
Southlake Hospital
Newmarket, Ontario, L3Y 2P9, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1CB, Canada
Centre Hospitalier De Universite of Montreal
Montreal, Quebec, H2W 1T8, Canada
Hospital Laval
Sainte-Foy, Quebec, G1V 4G5, Canada
University of Hradec Kralove
Hradec Králové, 5005 05, Czechia
Aarhus University Hospital
Aarhus, 8200, Denmark
Helsinki University Central Hospital
Helsinki, FIN-00029 HUS, Finland
Tampere University Hospital
Tampere, 33521, Finland
CHU Jean Minjoz
Besançon, 25030, France
CHU La Cavalle Blanche
Brest, 29609, France
Hôpital Privé Parly II
Le Chesnay, 78150, France
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, 92350, France
CHU La Timone
Marseille, 13005, France
Hôpital St Joseph
Marseille, 13008, France
Clinique Clairval
Marseille, 13009, France
Institut Hospitalier Jacques Cartier
Massy, 91300, France
CHU Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, 34295, France
Hopital Nord Laënnec
Nantes, 44093, France
Hopital Bichat
Paris, 75018, France
CHRU Pontchaillou
Rennes, 35033, France
C.H.U Charles Nicolle
Rouen, 76000, France
CHU Rangueil
Toulouse, 31059, France
Clinique Pasteur / GCVI
Toulouse, 31076, France
Clinique Saint-Gatien
Tours, 37000, France
Zentralklinik Bad Berka GmbH
Bad Berka, 99437, Germany
Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
Bad Krozingen, 79189, Germany
Kerckhoff Klinik
Bad Nauheim, 61231, Germany
Herz- und Gefäss-Klinik GmbH
Bad Neustadt an der Saale, 97616, Germany
Herz- und Diabeteszentrum NRW
Bad Oyenhausen, 32545, Germany
Evangelisch Freikirchliches Krankenhaus
Bernau, 16321, Germany
Universitätsklinikum
Cologne, 50937, Germany
Städtisches Klinikum
Dortmund, 44137, Germany
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, 01307, Germany
Universitätsklinik Erlangen
Erlangen, 91054, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
Universitatsmedizin Gottingen
Göttingen, 37075, Germany
Asklepios Klinik St Georg
Hamburg, 20099, Germany
Universitatsklinikum Eppendorf
Hamburg, 20246, Germany
Universitätsklinikum
Jena, 07747, Germany
KLINIKUM KARLSBURG der Klinikgruppe Dr. Guth GmbH & Co. KG
Karlsburg, 17495, Germany
Städtisches Klinikum Karlsruhe
Karlsruhe, 76133, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105, Germany
Herzzentrum Leipzig GmbH
Leipzig, 04289, Germany
Johannes Gutenberg Universität Mainz
Mainz, 55131, Germany
Deutsches Herzzentrum Muenchen
Munich, 80636, Germany
Klinikum Schwabing
Munich, 80804, Germany
Klinikum der Universität München - Großhadern
Munich, 81377, Germany
Klinikum Bogenhausen
Munich, 81925, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Klinikum Sud Nurnberg
Nuremberg, 90471, Germany
Universitatsklinikum Regensburg
Regensburg, 93053, Germany
SANA Herzzentrum
Stuttgart, 70174, Germany
Universitatsklinik Wurzburg
Würzburg, 97080, Germany
Hygeia Hospital
Athens, 15123, Greece
Rambam Medical Center
Haifa, 31095, Israel
Shaare Zedek
Jerusalem, 91031, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
The Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
Clinica Sant'Anna Hospital
Catanzaro, 83100, Italy
Ospedale Pasquinucci
Massa, 54100, Italy
Clinica Montevergine
Mercogliano, 83013, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Centro Cardiologico Monzino
Milan, 20138, Italy
Hesperia Hospital
Modena, 41125, Italy
Azienda Ospedaliera Policlinico Universitario
Padua, 35128, Italy
Istituto Clinico Humanitas
Rozzano Milano, 20089, Italy
Ospedale San Giovanni Battista
Torino, 10126, Italy
Maastricht UMC+
Maastricht, 6202 AZ, Netherlands
Universitetssykehuset Nord-Norge
Tromsø, 9038, Norway
The Cardinal Stefan Wyszyński Institute of Cardiology
Warsaw, 04-628, Poland
Sunninghill Hospital
Johannesburg, Gauteng, 2157, South Africa
St Augustine's Hospital
Durban, 4001, South Africa
Panorama Medi-Clinic
Grand Rapids, 7506, South Africa
UNITAS Hospital
Pretoria, South Africa
Vergelegen Medi-Clinic
Somerset West, 7130, South Africa
C.H.U. A Coruña
A Coruña, 15006, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario Vall Hebron
Barcelona, 8035, Spain
Policlinica Gipuzkoa
Donostia / San Sebastian, 20009, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital La Paz
Madrid, 28046, Spain
Hospital Virgen de Arrixaca
Murcia, 30120, Spain
Hospital Marques de Valdecilla
Santander, 39008, Spain
Hospital Virgen Macarena
Seville, 41007, Spain
Complexo Hospitalario Universitario de Vigo
Vigo, 36200, Spain
Inselspital Bern
Bern, 3010, Switzerland
Klinik im Park
Zurich, 8027, Switzerland
London Chest Hospital
London, E2 9JX, United Kingdom
St Thomas Hospital
London, SE1 7EH, United Kingdom
King's College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
St Mary's Hospital - Imperial College Healthcare NHS Trust, Hammersmith Hospital . Du Cane Road
London, W12 0HS, United Kingdom
The James Cook University Hospital
Middlesbrough, TS4 3BW, United Kingdom
Related Publications (1)
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.
PMID: 25946437DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olaf Wendler, MD, PhD, FRCS
olaf.wendler@kch.nhs.uk
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2010
First Posted
November 10, 2010
Study Start
September 1, 2010
Primary Completion
August 1, 2014
Study Completion
November 1, 2016
Last Updated
August 28, 2020
Record last verified: 2020-08