Clinical trial NCT01238497: SOURCE XT REGISTRY
Official title: Edwards SAPIEN™ Aortic Bioprosthesis Multi-Region Outcome Registry XT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Aortic Stenosis
Keywords: SAPIEN XT™
Transfemoral
NovaFlex
NovaFlex+
NF
NF+
Transapical
Transaortic
Ascendra2
Ascendra+
Asc+
aortic stenosis
aortic valve
Transcatheter Heart Valve
THV
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2010-11-10
Enrollment: 2954
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic aortic stenosis

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.

Eligibility criteria: Inclusion Criteria:

* 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"

Exclusion Criteria:

* 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

Primary outcomes:
measure: Assess and track causality and sequelae of major adverse events
timeFrame: 30 days
Secondary outcomes:
measure: Effectiveness: observe trends in patient characteristics and outcomes over time
timeFrame: One year
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Universitatsklinik Innsbruck
city: Vienna
country: Austria
facility: Medical University Vienna
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis
city: Bouge
country: Belgium
facility: Clinique St Luc
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Saint John
country: Canada
facility: St. John Regional Hospital
state: New Brunswick
city: Hamilton
country: Canada
facility: Hamilton Health Services
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier De Universite of Montreal
state: Quebec
city: Sainte-Foy
country: Canada
facility: Hospital Laval
state: Quebec
city: Hradec Kralove
country: Czechia
facility: University of Hradec Kralove
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Besançon
country: France
facility: CHU Jean Minjoz
city: Brest
country: France
facility: CHU La Cavalle Blanche
city: Le Chesnay
country: France
facility: Hôpital Privé Parly II
city: Le Plessis Robinson
country: France
facility: Centre Chirurgical Marie Lannelongue
city: Marseille
country: France
facility: CHU La Timone
city: Marseille
country: France
facility: Hôpital St Joseph
city: Marseille
country: France
facility: Clinique Clairval
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier
city: Montpellier
country: France
facility: CHU Montpellier - Hôpital Arnaud de Villeneuve
city: Nantes
country: France
facility: Hopital Nord Laënnec
city: Paris
country: France
facility: Hopital Bichat
city: Rennes
country: France
facility: CHRU Pontchaillou
city: Rouen
country: France
facility: C.H.U Charles Nicolle
city: Toulouse
country: France
facility: CHU Rangueil
city: Toulouse
country: France
facility: Clinique Pasteur / GCVI
city: Tours
country: France
facility: Clinique Saint-Gatien
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
city: Bad Neustadt
country: Germany
facility: Herz- und Gefäss-Klinik GmbH
city: Bad Oyenhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Bernau
country: Germany
facility: Evangelisch Freikirchliches Krankenhaus
city: Dortmund
country: Germany
facility: Städtisches Klinikum
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik
city: Erlangen
country: Germany
facility: Universitätsklinik Erlangen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Goettingen
country: Germany
facility: Universitatsmedizin Gottingen
city: Hamburg
country: Germany
facility: Asklepios Klinik St Georg
city: Hamburg
country: Germany
facility: Universitatsklinikum Eppendorf
city: Jena
country: Germany
facility: Universitätsklinikum
city: Karlsburg
country: Germany
facility: KLINIKUM KARLSBURG der Klinikgruppe Dr. Guth GmbH & Co. KG
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel
city: Köln
country: Germany
facility: Universitätsklinikum
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Mainz
country: Germany
facility: Johannes Gutenberg Universität Mainz
city: Muenster
country: Germany
facility: Universitätsklinikum Münster
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
city: Munich
country: Germany
facility: Klinikum Schwabing
city: Munich
country: Germany
facility: Klinikum der Universität München - Großhadern
city: Munich
country: Germany
facility: Klinikum Bogenhausen
city: Nurnberg
country: Germany
facility: Klinikum Sud Nurnberg
city: Regensburg
country: Germany
facility: Universitatsklinikum Regensburg
city: Stuttgart
country: Germany
facility: SANA Herzzentrum
city: Wurzburg
country: Germany
facility: Universitatsklinik Wurzburg
city: Athens
country: Greece
facility: Hygeia Hospital
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Catanzaro
country: Italy
facility: Clinica Sant'Anna Hospital
city: Massa
country: Italy
facility: Ospedale Pasquinucci
city: Mercogliano
country: Italy
facility: Clinica Montevergine
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Modena
country: Italy
facility: Hesperia Hospital
city: Padova
country: Italy
facility: Azienda Ospedaliera Policlinico Universitario
city: Rozzano Milano
country: Italy
facility: Istituto Clinico Humanitas
city: Torino
country: Italy
facility: Ospedale San Giovanni Battista
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
city: Tromso
country: Norway
facility: Universitetssykehuset Nord-Norge
city: Warsaw
country: Poland
facility: The Cardinal Stefan Wyszyński Institute of Cardiology
city: Johannesburg
country: South Africa
facility: Sunninghill Hospital
state: Gauteng
city: Durban
country: South Africa
facility: St Augustine's Hospital
city: Grand Rapids
country: South Africa
facility: Panorama Medi-Clinic
city: Pretoria
country: South Africa
facility: UNITAS Hospital
city: Somerset West
country: South Africa
facility: Vergelegen Medi-Clinic
city: A Coruña
country: Spain
facility: C.H.U. A Coruña
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario Vall Hebron
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital La Paz
city: Murcia
country: Spain
facility: Hospital Virgen de Arrixaca
city: San Sebastian
country: Spain
facility: Policlinica Gipuzkoa
city: Santander
country: Spain
facility: Hospital Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Vigo
country: Spain
facility: Complexo Hospitalario Universitario de Vigo
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Zurich
country: Switzerland
facility: Klinik im Park
city: London
country: United Kingdom
facility: London Chest Hospital
city: London
country: United Kingdom
facility: St Thomas Hospital
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: St Mary's Hospital - Imperial College Healthcare NHS Trust, Hammersmith Hospital . Du Cane Road
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital
Study officials:
affiliation: olaf.wendler@kch.nhs.uk
name: Olaf Wendler, MD, PhD, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.