Atrial FibrillationABLATORNCT02344173
ABLATOR Ablation Observational Registry
An observational study of Atrial Fibrillation, run by Abbott Medical Devices at 62 sites in 15 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 2,035 participants
- Where
- 62 sitesin 15 countries
- Study dates
- Nov 2014to 18 Aug 2017
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who are indicated for an atrial fibrillation ablation procedure.
Who may be able to join
- All patients who are indicated for an atrial fibrillation ablation procedure.
Who cannot join
- Pregnant women.
Trial locations and contacts
62 sites in 15 countries.
62 sites in 15 countries
Germany12 sites
Zentralklinikum Bad Berka
Bad Berka
Herz- und Gefässzentrum Bad Bevensen
Bad Bevensen
Kerckhoff Klinik
Bad Nauheim
Vivantes Klinikum Am Urban
Berlin
Immanuel Klinikum Bernau - Herzzentrum Brandenburg
Bernau
Universitätsklinikum Köln
Cologne
Herz- und Gefässzentrum am Krankenhaus Neu-Bethlehem
Göttingen
Universitätsklinikum Heidelberg
Heidelberg
Herzzentrum Leipzig
Leipzig
Märkische Kliniken GmbH Klinikum Lüdenscheid
Lüdenscheid
Klinikum Ludwigshafen
Ludwigshafen
Kliniken Maria Hilf
Mönchengladbach
China6 sites
Fuwai Heart Hospital & Cardiovascular Institute
Beijing
Third Xiangya Hospital of Central South University
Changsha
West China Hospital
Chengdu
Sir Run Run Shaw Hospital
Hangzhou
Prince of Wales Hospital
Hong Kong
Ningbo 1st. Hospital
Ningbo
Italy6 sites
Ospedale SS Antonio e Biagio
Alessandria
Ospedale Cardinal Massaia
Asti, Piedmon, 14100
Fondazione Giovanni Paolo II
Campobasso
Ospedale San Giovanni di Dio - Torregalli
Florence, Tuscany, 50122
Ospedale Spirito Santo
Pescara
Ospedale San Filippo Neri
Roma
France5 sites
Clinique Rhône-Durance-Avignon
Avignon
CHU Brest
Brest
CHU Gabriel Montpied
Clermont-Ferrand
CHRU Lille
Lille
Clinique Pasteur
Toulouse
Spain5 sites
Hospital general Universitario de Alicante
Alicante
Hospital Universitario de Bellvitge
Barcelona
Hospital Virgen de las Nieves
Granada
Hospital Clinico Universitario de Valladolid
Valladolid
Hospital do Meixoeiro
Vigo
Canada4 sites
Foothills Medical Center
Calgary
QE II Health Sciences
Hailfax
Royal Jubilee hospital
Newmarket
Institut de Cardiologie de Quebec (Hôpital Laval)
Québec
India4 sites
Fortis Hospital Limited
Bangalore
Medanta - The Medicity Hospital
Gūrgaon
Escorts Heart Institute and Research Centre
New Delhi
Christian Medical College & Hospital
Vellore
South Korea4 sites
Yeungnam University Medical Center
Daegu
Korea University Anam Hospital
Seoul
Samsung Medical Center
Seoul
Yonsei University Health System
Seoul
United Kingdom4 sites
Royal Bournemouth Hospital
Bournemouth
Royal Sussex County Hospital
Brighton
Castle Hill Hospital
Hull
Leeds General Infirmary
Leeds
Belgium3 sites
AZ Middelheim
Antwerp
Jessa Ziekenhuis
Hasselt
CHR Citadelle
Liège
Netherlands3 sites
Catharina Hospital
Eindhoven
Erasmus Rotterdam
Rotterdam
Haga Hospital
The Hague
Portugal3 sites
Hospital Santa Cruz
Carnaxide
Hospital Santa Maria
Lisbon
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia
About this study
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).
Read the 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.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 12 months post procedure
Number of Subjects That Experienced 1 or More Procedure and/or Device-related Cardiovascular SAE/SADEs.
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.
Measured: 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startNov 2014
- Primary completion18 Aug 2017
- Study completion18 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,035 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344173
- Sponsor's protocol ID
- CRD_723
- Acronym
- ABLATOR
- Status last verified
- Feb 2019
- First submitted
- 13 Jan 2015
- Last updated
- 5 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABLATOR Ablation Observational Registry
- ClinicalTrials.gov ID
- NCT02344173
- Acronym / sponsor ID
- ABLATOR / CRD_723
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,035 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- 18 Aug 2017 (actual)
- Study completion
- 18 Aug 2017 (actual)
- First posted
- 22 Jan 2015 (estimated)
- Results
- Posted 5 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who are indicated for an atrial fibrillation ablation procedure.
Key inclusion criteria (1 listed)
- All patients who are indicated for an atrial fibrillation ablation procedure.
Key exclusion criteria (1 listed)
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
62 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Abbott Medical Devices at 62 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in Germany, China, Italy, France, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 12 months post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.