ABLATOR Ablation Observational Registry

NCT ID: NCT02344173

Last Updated: 2019-06-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2035 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-08-18

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Pregnant women.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Allgemeines Krankenhaus Linz

Linz, , Austria

Site Status

AZ Middelheim

Antwerp, , Belgium

Site Status

Jessa Ziekenhuis

Hasselt, , Belgium

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CHR Citadelle

Liège, , Belgium

Site Status

Foothills Medical Center

Calgary, , Canada

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QE II Health Sciences

Hailfax, , Canada

Site Status

Royal Jubilee hospital

Newmarket, , Canada

Site Status

Institut de Cardiologie de Quebec (Hôpital Laval)

Québec, , Canada

Site Status

Fuwai Heart Hospital & Cardiovascular Institute

Beijing, , China

Site Status

Third Xiangya Hospital of Central South University

Changsha, , China

Site Status

West China Hospital

Chengdu, , China

Site Status

Sir Run Run Shaw Hospital

Hangzhou, , China

Site Status

Prince of Wales Hospital

Hong Kong, , China

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Ningbo 1st. Hospital

Ningbo, , China

Site Status

FN U sv. Anny v Brno

Brno, , Czechia

Site Status

Clinique Rhône-Durance-Avignon

Avignon, , France

Site Status

CHU Brest

Brest, , France

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CHU Gabriel Montpied

Clermont-Ferrand, , France

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CHRU Lille

Lille, , France

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Clinique Pasteur

Toulouse, , France

Site Status

Zentralklinikum Bad Berka

Bad Berka, , Germany

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Herz- und Gefässzentrum Bad Bevensen

Bad Bevensen, , Germany

Site Status

Kerckhoff Klinik

Bad Nauheim, , Germany

Site Status

Vivantes Klinikum Am Urban

Berlin, , Germany

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Immanuel Klinikum Bernau - Herzzentrum Brandenburg

Bernau, , Germany

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Universitätsklinikum Köln

Cologne, , Germany

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Herz- und Gefässzentrum am Krankenhaus Neu-Bethlehem

Göttingen, , Germany

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Universitätsklinikum Heidelberg

Heidelberg, , Germany

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Herzzentrum Leipzig

Leipzig, , Germany

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Klinikum Ludwigshafen

Ludwigshafen, , Germany

Site Status

Märkische Kliniken GmbH Klinikum Lüdenscheid

Lüdenscheid, , Germany

Site Status

Kliniken Maria Hilf

Mönchengladbach, , Germany

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Fortis Hospital Limited

Bangalore, , India

Site Status

Medanta - The Medicity Hospital

Gurgaon, , India

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Escorts Heart Institute and Research Centre

New Delhi, , India

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Christian Medical College & Hospital

Vellore, , India

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Ospedale Cardinal Massaia

Asti, Piedmon, Italy

Site Status

Ospedale San Giovanni di Dio - Torregalli

Florence, Tuscany, Italy

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Ospedale SS Antonio e Biagio

Alessandria, , Italy

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Fondazione Giovanni Paolo II

Campobasso, , Italy

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Ospedale Spirito Santo

Pescara, , Italy

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Ospedale San Filippo Neri

Roma, , Italy

Site Status

Catharina Hospital

Eindhoven, , Netherlands

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Erasmus Rotterdam

Rotterdam, , Netherlands

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Haga Hospital

The Hague, , Netherlands

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Hospital Santa Cruz

Carnaxide, , Portugal

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Hospital Santa Maria

Lisbon, , Portugal

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Centro Hospitalar de Vila Nova de Gaia

Vila Nova de Gaia, , Portugal

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Prince Sultan Cardiac Center

Riyadh, , Saudi Arabia

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Yeungnam University Medical Center

Daegu, , South Korea

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Korea University Anam Hospital

Seoul, , South Korea

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Samsung Medical Center

Seoul, , South Korea

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Yonsei University Health System

Seoul, , South Korea

Site Status

Hospital general Universitario de Alicante

Alicante, , Spain

Site Status

Hospital Universitario de Bellvitge

Barcelona, , Spain

Site Status

Hospital Virgen de las Nieves

Granada, , Spain

Site Status

Hospital Clinico Universitario de Valladolid

Valladolid, , Spain

Site Status

Hospital do Meixoeiro

Vigo, , Spain

Site Status

Royal Bournemouth Hospital

Bournemouth, , United Kingdom

Site Status

Royal Sussex County Hospital

Brighton, , United Kingdom

Site Status

Castle Hill Hospital

Hull, , United Kingdom

Site Status

Leeds General Infirmary

Leeds, , United Kingdom

Site Status

Countries

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Austria Belgium Canada China Czechia France Germany India Italy Netherlands Portugal Saudi Arabia South Korea Spain United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CRD_723

Identifier Type: -

Identifier Source: org_study_id

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