Clinical trial NCT02344173: ABLATOR Ablation Observational Registry
Official title: ABLATOR Ablation Observational Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-01-22
Enrollment: 2035
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who are indicated for an atrial fibrillation ablation procedure.

Brief summary: The purpose of this registry is to assess the performance and clinical effectiveness of a combination of SJM mapping and ablation products in the treatment of subjects with atrial fibrillation (AF).

Detailed description: The objectives of this registry are the following:

* 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.

Eligibility criteria: Inclusion Criteria:

All patients who are indicated for an atrial fibrillation ablation procedure.

Exclusion Criteria:

Pregnant women.

Primary outcomes:
measure: Number of Subjects That Achieved Freedom From AF/AFL/AT (Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia) With or Without the Use of Anti-arrhythmic Drugs After a 3-month Blanking Period.
timeFrame: 12 months post procedure
measure: Number of Subjects That Experienced 1 or More Procedure and/or Device-related Cardiovascular SAE/SADEs.
timeFrame: 12 months post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Allgemeines Krankenhaus Linz
city: Antwerpen
country: Belgium
facility: AZ Middelheim
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Liège
country: Belgium
facility: CHR Citadelle
city: Calgary
country: Canada
facility: Foothills Medical Center
city: Hailfax
country: Canada
facility: QE II Health Sciences
city: Newmarket
country: Canada
facility: Royal Jubilee hospital
city: Quebec
country: Canada
facility: Institut de Cardiologie de Quebec (Hôpital Laval)
city: Beijing
country: China
facility: Fuwai Heart Hospital & Cardiovascular Institute
city: Changsha
country: China
facility: Third Xiangya Hospital of Central South University
city: Chengdu
country: China
facility: West China Hospital
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
city: Hong Kong
country: China
facility: Prince of Wales Hospital
city: Ningbo
country: China
facility: Ningbo 1st. Hospital
city: Brno
country: Czechia
facility: FN U sv. Anny v Brno
city: Avignon
country: France
facility: Clinique Rhône-Durance-Avignon
city: Brest
country: France
facility: CHU Brest
city: Clermont-Ferrand
country: France
facility: CHU Gabriel Montpied
city: Lille
country: France
facility: CHRU Lille
city: Toulouse
country: France
facility: Clinique Pasteur
city: Bad Berka
country: Germany
facility: Zentralklinikum Bad Berka
city: Bad Bevensen
country: Germany
facility: Herz- und Gefässzentrum Bad Bevensen
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
city: Berlin
country: Germany
facility: Vivantes Klinikum Am Urban
city: Bernau
country: Germany
facility: Immanuel Klinikum Bernau - Herzzentrum Brandenburg
city: Göttingen
country: Germany
facility: Herz- und Gefässzentrum am Krankenhaus Neu-Bethlehem
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Ludwigshafen
country: Germany
facility: Klinikum Ludwigshafen
city: Lüdenscheid
country: Germany
facility: Märkische Kliniken GmbH Klinikum Lüdenscheid
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf
city: Bangalore
country: India
facility: Fortis Hospital Limited
city: Gurgaon
country: India
facility: Medanta - The Medicity Hospital
city: New Delhi
country: India
facility: Escorts Heart Institute and Research Centre
city: Vellore
country: India
facility: Christian Medical College & Hospital
city: Asti
country: Italy
facility: Ospedale Cardinal Massaia
state: Piedmon
city: Firenze
country: Italy
facility: Ospedale San Giovanni di Dio - Torregalli
state: Toscane
city: Alessandria
country: Italy
facility: Ospedale SS Antonio e Biagio
city: Campobasso
country: Italy
facility: Fondazione Giovanni Paolo II
city: Pescara
country: Italy
facility: Ospedale Spirito Santo
city: Roma
country: Italy
facility: Ospedale San Filippo Neri
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System
city: Den Haag
country: Netherlands
facility: Haga Hospital
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus Rotterdam
city: Carnaxide
country: Portugal
facility: Hospital Santa Cruz
city: Lisbon
country: Portugal
facility: Hospital Santa Maria
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia
city: Riyadh
country: Saudi Arabia
facility: Prince Sultan Cardiac Center
city: Alicante
country: Spain
facility: Hospital general Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Universitario de Bellvitge
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Vigo
country: Spain
facility: Hospital do Meixoeiro
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Hull
country: United Kingdom
facility: Castle Hill Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
Study officials:
References: