ABLATOR Ablation Observational Registry
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT02344173
- Lead Sponsor
- Abbott Medical Devices
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2035
All patients who are indicated for an atrial fibrillation ablation procedure.
Pregnant women.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. 12 months post procedure 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. Repeat ablations during the 3-month blanking period do not count as effectiveness failures. A repeat ablation procedure after the 3-month blanking period is counted as an effectiveness failure.
Number of Subjects That Experienced 1 or More Procedure and/or Device-related Cardiovascular SAE/SADEs. 12 months post procedure Procedure and/or Device-Related Cardiovascular SAE/SADEs. This registry collected information about adverse events deemed of cardiovascular origin ("Cardiovascular Serious Adverse Event") with the potential of leading to:
* Death
* A serious deterioration in the health of the subject
* Fetal distress, fetal death or a congenital abnormality or birth defect
A planned hospitalization for a pre-existing condition was not considered a serious adverse event. Reporting of non-serious events and non-cardiovascular events was not required.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (62)
Allgemeines Krankenhaus Linz
🇦🇹Linz, Austria
AZ Middelheim
🇧🇪Antwerpen, Belgium
Jessa Ziekenhuis
🇧🇪Hasselt, Belgium
CHR Citadelle
🇧🇪Liège, Belgium
Institut de Cardiologie de Quebec (Hôpital Laval)
🇨🇦Quebec, Canada
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Herzzentrum Leipzig
🇩🇪Leipzig, Germany
Klinikum Ludwigshafen
🇩🇪Ludwigshafen, Germany
Vivantes Klinikum Am Urban
🇩🇪Berlin, Germany
Foothills Medical Center
🇨🇦Calgary, Canada
QE II Health Sciences
🇨🇦Hailfax, Canada
Royal Jubilee hospital
🇨🇦Newmarket, Canada
Fuwai Heart Hospital & Cardiovascular Institute
🇨🇳Beijing, China
Third Xiangya Hospital of Central South University
🇨🇳Changsha, China
Prince of Wales Hospital
🇨🇳Hong Kong, China
CHU Brest
🇫🇷Brest, France
Ningbo 1st. Hospital
🇨🇳Ningbo, China
Clinique Rhône-Durance-Avignon
🇫🇷Avignon, France
Fortis Hospital Limited
🇮🇳Bangalore, India
Medanta - The Medicity Hospital
🇮🇳Gurgaon, India
Ospedale SS Antonio e Biagio
🇮🇹Alessandria, Italy
Herz- und Gefässzentrum Bad Bevensen
🇩🇪Bad Bevensen, Germany
Immanuel Klinikum Bernau - Herzzentrum Brandenburg
🇩🇪Bernau, Germany
Clinique Pasteur
🇫🇷Toulouse, France
Zentralklinikum Bad Berka
🇩🇪Bad Berka, Germany
Herz- und Gefässzentrum am Krankenhaus Neu-Bethlehem
🇩🇪Göttingen, Germany
Universitätsklinikum Köln
🇩🇪Köln, Germany
Märkische Kliniken GmbH Klinikum Lüdenscheid
🇩🇪Lüdenscheid, Germany
Kerckhoff Klinik
🇩🇪Bad Nauheim, Germany
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Erasmus Rotterdam
🇳🇱Rotterdam, Netherlands
Haga Hospital
🇳🇱Den Haag, Netherlands
Catharina Hospital
🇳🇱Eindhoven, Netherlands
Hospital Santa Maria
🇵🇹Lisbon, Portugal
Ospedale San Filippo Neri
🇮🇹Roma, Italy
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital Santa Cruz
🇵🇹Carnaxide, Portugal
Prince Sultan Cardiac Center
🇸🇦Riyadh, Saudi Arabia
Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
CHU Gabriel Montpied
🇫🇷Clermont-Ferrand, France
CHRU Lille
🇫🇷Lille, France
Kliniken Maria Hilf
🇩🇪Mönchengladbach, Germany
Christian Medical College & Hospital
🇮🇳Vellore, India
Escorts Heart Institute and Research Centre
🇮🇳New Delhi, India
Fondazione Giovanni Paolo II
🇮🇹Campobasso, Italy
Ospedale Cardinal Massaia
🇮🇹Asti, Piedmon, Italy
Ospedale San Giovanni di Dio - Torregalli
🇮🇹Firenze, Toscane, Italy
Ospedale Spirito Santo
🇮🇹Pescara, Italy
Centro Hospitalar de Vila Nova de Gaia
🇵🇹Vila Nova de Gaia, Portugal
Hospital general Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Universitario de Bellvitge
🇪🇸Barcelona, Spain
Hospital Virgen de las Nieves
🇪🇸Granada, Spain
Hospital do Meixoeiro
🇪🇸Vigo, Spain
Hospital Clinico Universitario de Valladolid
🇪🇸Valladolid, Spain
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
West China Hospital
🇨🇳Chengdu, China
Sir Run Run Shaw Hospital
🇨🇳Hangzhou, China
FN U sv. Anny v Brno
🇨🇿Brno, Czechia
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
Castle Hill Hospital
🇬🇧Hull, United Kingdom