ABLATOR Ablation Observational Registry (ABLATOR)

February 25, 2019 updated by: Abbott Medical Devices
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).

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

2035

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria
        • Allgemeines Krankenhaus Linz
  • Belgium
      • Antwerpen, Belgium
        • Az Middelheim
      • Hasselt, Belgium
        • Jessa Ziekenhuis
      • Liège, Belgium
        • CHR Citadelle
  • Canada
      • Calgary, Canada
        • Foothills Medical Center
      • Hailfax, Canada
        • QE II Health Sciences
      • Newmarket, Canada
        • Royal Jubilee Hospital
      • Quebec, Canada
        • Institut de Cardiologie de Quebec (Hôpital Laval)
  • China
      • Beijing, China
        • Fuwai Heart Hospital & Cardiovascular Institute
      • Changsha, China
        • Third Xiangya Hospital of Central South University
      • Chengdu, China
        • West China Hospital
      • Hangzhou, China
        • Sir Run Run Shaw Hospital
      • Hong Kong, China
        • Prince of Wales Hospital
      • Ningbo, China
        • Ningbo 1st. Hospital
  • Czechia
      • Brno, Czechia
        • FN U sv. Anny v Brno
  • France
      • Avignon, France
        • Clinique Rhône-Durance-Avignon
      • Brest, France
        • CHU Brest
      • Clermont-Ferrand, France
        • Chu Gabriel Montpied
      • Lille, France
        • CHRU LILLE
      • Toulouse, France
        • Clinique Pasteur
  • Germany
      • Bad Berka, Germany
        • Zentralklinikum Bad berka
      • Bad Bevensen, Germany
        • Herz- und Gefasszentrum Bad Bevensen
      • Bad Nauheim, Germany
        • Kerckhoff Klinik
      • Berlin, Germany
        • Vivantes Klinikum Am Urban
      • Bernau, Germany
        • Immanuel Klinikum Bernau - Herzzentrum Brandenburg
      • Göttingen, Germany
        • Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem
      • Heidelberg, Germany
        • Universitätsklinikum Heidelberg
      • Köln, Germany
        • Universitätsklinikum Köln
      • Leipzig, Germany
        • Herzzentrum Leipzig
      • Ludwigshafen, Germany
        • Klinikum Ludwigshafen
      • Lüdenscheid, Germany
        • Märkische Kliniken GmbH Klinikum Lüdenscheid
      • Mönchengladbach, Germany
        • Kliniken Maria Hilf
  • India
      • Bangalore, India
        • Fortis Hospital Limited
      • Gurgaon, India
        • Medanta - The Medicity Hospital
      • New Delhi, India
        • Escorts Heart Institute and Research Centre
      • Vellore, India
        • Christian Medical College & Hospital
  • Italy
      • Alessandria, Italy
        • Ospedale SS Antonio e Biagio
      • Campobasso, Italy
        • Fondazione Giovanni Paolo II
      • Pescara, Italy
        • Ospedale Spirito Santo
      • Roma, Italy
        • Ospedale San Filippo Neri
    • Piedmon
      • Asti, Piedmon, Italy, 14100
        • Ospedale Cardinal Massaia
    • Toscane
      • Firenze, Toscane, Italy, 50122
        • Ospedale San Giovanni di Dio - Torregalli
  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Yeungnam University Medical Center
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • Yonsei University Health System
  • Netherlands
      • Den Haag, Netherlands
        • Haga hospital
      • Eindhoven, Netherlands
        • Catharina Hospital
      • Rotterdam, Netherlands
        • Erasmus Rotterdam
  • Portugal
      • Carnaxide, Portugal
        • Hospital Santa Cruz
      • Lisbon, Portugal
        • Hospital Santa Maria
      • Vila Nova de Gaia, Portugal
        • Centro Hospitalar de Vila Nova de Gaia
  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • Prince Sultan Cardiac Center
  • Spain
      • Alicante, Spain
        • Hospital General Universitario de Alicante
      • Barcelona, Spain
        • Hospital Universitario de Bellvitge
      • Granada, Spain
        • Hospital Virgen de las Nieves
      • Valladolid, Spain
        • Hospital Clinico Universitario de Valladolid
      • Vigo, Spain
        • Hospital Do Meixoeiro
  • United Kingdom
      • Bournemouth, United Kingdom
        • Royal Bournemouth Hospital
      • Brighton, United Kingdom
        • Royal Sussex County Hospital
      • Hull, United Kingdom
        • Castle Hill Hospital
      • Leeds, United Kingdom
        • Leeds General Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
12 months post procedure
Number of Subjects That Experienced 1 or More Procedure and/or Device-related Cardiovascular SAE/SADEs.
Time Frame: 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.
12 months post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

August 18, 2017

Study Completion (Actual)

August 18, 2017

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 16, 2015

First Posted (Estimate)

January 22, 2015

Study Record Updates

Last Update Posted (Actual)

June 5, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD_723

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe