Study Results
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View full resultsBasic Information
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COMPLETED
2035 participants
OBSERVATIONAL
2014-11-30
2017-08-18
Brief Summary
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Detailed Description
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* To confirm patient safety as part of the post market surveillance study.
* To assess performance of a combination of SJM products during procedures.
* To assess the learning curve with a combination of SJM products.
* To collect operator feedback on a combination of SJM products.
All patients from participating sites who are indicated for an atrial fibrillation ablation procedure and willing to provide written Informed Consent may be enrolled in this registry.
In order to ensure a minimum level of uniformity across site practices and to enable comparison of acute and long-term effectiveness as well as procedure efficiency according to technique used, a combination of 2 types of devices from the pre-specified list must be used to be eligible in this registry.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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Allgemeines Krankenhaus Linz
Linz, , Austria
AZ Middelheim
Antwerp, , Belgium
Jessa Ziekenhuis
Hasselt, , Belgium
CHR Citadelle
Liège, , Belgium
Foothills Medical Center
Calgary, , Canada
QE II Health Sciences
Hailfax, , Canada
Royal Jubilee hospital
Newmarket, , Canada
Institut de Cardiologie de Quebec (Hôpital Laval)
Québec, , Canada
Fuwai Heart Hospital & Cardiovascular Institute
Beijing, , China
Third Xiangya Hospital of Central South University
Changsha, , China
West China Hospital
Chengdu, , China
Sir Run Run Shaw Hospital
Hangzhou, , China
Prince of Wales Hospital
Hong Kong, , China
Ningbo 1st. Hospital
Ningbo, , China
FN U sv. Anny v Brno
Brno, , Czechia
Clinique Rhône-Durance-Avignon
Avignon, , France
CHU Brest
Brest, , France
CHU Gabriel Montpied
Clermont-Ferrand, , France
CHRU Lille
Lille, , France
Clinique Pasteur
Toulouse, , France
Zentralklinikum Bad Berka
Bad Berka, , Germany
Herz- und Gefässzentrum Bad Bevensen
Bad Bevensen, , Germany
Kerckhoff Klinik
Bad Nauheim, , Germany
Vivantes Klinikum Am Urban
Berlin, , Germany
Immanuel Klinikum Bernau - Herzzentrum Brandenburg
Bernau, , Germany
Universitätsklinikum Köln
Cologne, , Germany
Herz- und Gefässzentrum am Krankenhaus Neu-Bethlehem
Göttingen, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Herzzentrum Leipzig
Leipzig, , Germany
Klinikum Ludwigshafen
Ludwigshafen, , Germany
Märkische Kliniken GmbH Klinikum Lüdenscheid
Lüdenscheid, , Germany
Kliniken Maria Hilf
Mönchengladbach, , Germany
Fortis Hospital Limited
Bangalore, , India
Medanta - The Medicity Hospital
Gurgaon, , India
Escorts Heart Institute and Research Centre
New Delhi, , India
Christian Medical College & Hospital
Vellore, , India
Ospedale Cardinal Massaia
Asti, Piedmon, Italy
Ospedale San Giovanni di Dio - Torregalli
Florence, Tuscany, Italy
Ospedale SS Antonio e Biagio
Alessandria, , Italy
Fondazione Giovanni Paolo II
Campobasso, , Italy
Ospedale Spirito Santo
Pescara, , Italy
Ospedale San Filippo Neri
Roma, , Italy
Catharina Hospital
Eindhoven, , Netherlands
Erasmus Rotterdam
Rotterdam, , Netherlands
Haga Hospital
The Hague, , Netherlands
Hospital Santa Cruz
Carnaxide, , Portugal
Hospital Santa Maria
Lisbon, , Portugal
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, , Portugal
Prince Sultan Cardiac Center
Riyadh, , Saudi Arabia
Yeungnam University Medical Center
Daegu, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Yonsei University Health System
Seoul, , South Korea
Hospital general Universitario de Alicante
Alicante, , Spain
Hospital Universitario de Bellvitge
Barcelona, , Spain
Hospital Virgen de las Nieves
Granada, , Spain
Hospital Clinico Universitario de Valladolid
Valladolid, , Spain
Hospital do Meixoeiro
Vigo, , Spain
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Royal Sussex County Hospital
Brighton, , United Kingdom
Castle Hill Hospital
Hull, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CRD_723
Identifier Type: -
Identifier Source: org_study_id
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