SOURCE XT REGISTRY

Severe Aortic Stenosis Clinical Trial

Official title:

Edwards SAPIEN™ Aortic Bioprosthesis Multi-Region Outcome Registry XT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01238497
• Other study ID #: 2010-10
• Status: Completed
• Start date: September 2010
• Est. completion date: November 2016

Study information

• Verified date: August 2020
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2954
• Est. completion date: November 2016
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Severe Aortic Stenosis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Austria	Universitatsklinik Innsbruck	Innsbruck
Austria	Medical University Vienna	Vienna
Belgium	Onze Lieve Vrouw Ziekenhuis	Aalst
Belgium	Clinique St Luc	Bouge
Belgium	Cliniques Universitaires Saint Luc	Brussels
Belgium	Universitaire Ziekenhuizen Leuven	Leuven
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Hamilton Health Services	Hamilton	Ontario
Canada	Centre Hospitalier De Universite of Montreal	Montreal	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Southlake Hospital	Newmarket	Ontario
Canada	St. John Regional Hospital	Saint John	New Brunswick
Canada	Hospital Laval	Sainte-Foy	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Czechia	University of Hradec Kralove	Hradec Kralove
Denmark	Aarhus University Hospital	Aarhus
Finland	Helsinki University Central Hospital	Helsinki
Finland	Tampere University Hospital	Tampere
France	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	Clinique Clairval	Marseille
France	Hôpital St Joseph	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
Germany	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
Germany	Herz- und Diabeteszentrum NRW	Bad Oyenhausen
Germany	Evangelisch Freikirchliches Krankenhaus	Bernau
Germany	Städtisches Klinikum	Dortmund
Germany	Herzzentrum Dresden GmbH Universitätsklinik	Dresden
Germany	Universitätsklinik Erlangen	Erlangen
Germany	Universitätsklinikum Essen	Essen
Germany	Universitatsmedizin Gottingen	Goettingen
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	Universitätsklinikum	Köln
Germany	Herzzentrum Leipzig GmbH	Leipzig
Germany	Johannes Gutenberg Universität Mainz	Mainz
Germany	Universitätsklinikum Münster	Muenster
Germany	Deutsches Herzzentrum Muenchen	Munich
Germany	Klinikum Bogenhausen	Munich
Germany	Klinikum der Universität München - Großhadern	Munich
Germany	Klinikum Schwabing	Munich
Germany	Klinikum Sud Nurnberg	Nurnberg
Germany	Universitatsklinikum Regensburg	Regensburg
Germany	SANA Herzzentrum	Stuttgart
Germany	Universitatsklinik Wurzburg	Wurzburg
Greece	Hygeia Hospital	Athens
Israel	Rambam Medical Center	Haifa
Israel	Shaare Zedek	Jerusalem
Israel	Rabin Medical Center	Petach Tikva
Israel	The Chaim Sheba Medical Center	Tel Hashomer
Italy	Clinica Sant'Anna Hospital	Catanzaro
Italy	Ospedale Pasquinucci	Massa
Italy	Clinica Montevergine	Mercogliano
Italy	Centro Cardiologico Monzino	Milano
Italy	Ospedale San Raffaele	Milano
Italy	Hesperia Hospital	Modena
Italy	Azienda Ospedaliera Policlinico Universitario	Padova
Italy	Istituto Clinico Humanitas	Rozzano Milano
Italy	Ospedale San Giovanni Battista	Torino
Netherlands	Maastricht UMC+	Maastricht
Norway	Universitetssykehuset Nord-Norge	Tromso
Poland	The Cardinal Stefan Wyszynski Institute of Cardiology	Warsaw
South Africa	St Augustine's Hospital	Durban
South Africa	Panorama Medi-Clinic	Grand Rapids
South Africa	Sunninghill Hospital	Johannesburg	Gauteng
South Africa	UNITAS Hospital	Pretoria
South Africa	Vergelegen Medi-Clinic	Somerset West
Spain	C.H.U. A Coruña	A Coruña
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitario Vall Hebron	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Virgen de Arrixaca	Murcia
Spain	Policlinica Gipuzkoa	San Sebastian
Spain	Hospital Marques de Valdecilla	Santander
Spain	Hospital Virgen Macarena	Sevilla
Spain	Complexo Hospitalario Universitario de Vigo	Vigo
Switzerland	Inselspital Bern	Bern
Switzerland	Klinik im Park	Zurich
United Kingdom	King's College Hospital NHS Foundation Trust	London
United Kingdom	London Chest Hospital	London
United Kingdom	St Mary's Hospital - Imperial College Healthcare NHS Trust, Hammersmith Hospital . Du Cane Road	London
United Kingdom	St Thomas Hospital	London
United Kingdom	The James Cook University Hospital	Middlesbrough

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Israel,  Italy,  Netherlands,  Norway,  Poland,  South Africa,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess and track causality and sequelae of major adverse events		30 days
Secondary	Effectiveness: observe trends in patient characteristics and outcomes over time		One year