Atrial FibrillationNCT02386345
Topera E-FIRM Registry
An observational study of Atrial Fibrillation, run by Abbott Medical Devices at 9 sites in 2 countries.
Trial summary
This is a registry to assess the safety and effectiveness of FIRM guided procedures for the treatment of symptomatic any type of atrial fibrillation. FIRM (Focal Impulse and Rotor Modulation) guided ablation is defined as ablating rotors identified by the FIRMap® basket catheter for visualising of rotors with the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 299 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Mar 2015to 31 Jul 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects who are receiving a FIRM guided AF ablation and are selected in accordance with the current AF guidelines are eligible for the participation in the registry
Who may be able to join
- reported incidence of at least 2 documented episodes of symptomatic AF (paroxysmal, persistent or long standing persistent) during the 3 months preceding the initial AF ablation attempt of at least one Class I or III anti-arrhythmia drug with failure defined as recurrence of symptomatic AF or adverse drug effect resulting in stopping medication
Who cannot join
- women who are pregnant
- As this is a registry only data of patients will be included who have been treated according to the current AF guidelines.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Germany8 sites
Herz- und Gefäßklinik
Bad Neustadt an der Saale, Bavaria, 97616
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, North Rhine-Westphalia, 32545
Unfallkrankenhaus Berlin
Berlin, 12683
Klinikum Coburg GmbH
Coburg, Bavaria, 96450
Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR
Dresden, Saxony, 01099
Städtisches Klinikum Karlsruhe GmbH
Karlsruhe, Baden-Würtemberg, 76133
Herzzentrum Leipzig
Leipzig, Saxony, 04289
Kardiologische Gemeinschaftspraxis am Park Sanssouci
Potsdam, Brandenburg, 14471
About this study
Official title: EU Focal Impulse and Rotor Modulation Registry -Topera E-FIRM Registry-
This is a registry to assess the safety and effectiveness of FIRM guided procedures for the treatment of symptomatic any type of atrial fibrillation.
FIRM (Focal Impulse and Rotor Modulation) guided ablation is defined as ablating rotors identified by the FIRMap® basket catheter for visualising of rotors with the RhythmView® mapping system. In addition to the FIRM guided ablation any other ablation method could be applied.The acute success of FIRM ablations is defined as elimination of rotors defined by absence of rotors.
Data items will be collected, if available, consistent and applicable with routine and standard clinical care at each participating site.
Read the detailed description
Prospective and retrospective enrollment is possible.
- Conditions
- Atrial Fibrillation
- Keywords
- FIRM procedure
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Acute Success
Acute Success was defined as the elimination (by ablation) of all identified rotors
Measured: day of procedure
Number of Participants With 12-Month Success
Single procedure freedom from atrial fibrillation recurrence
Measured: 12-months after index procedure
Number of Participants With Acute Safety Success
Acute safety success was defined as freedom from Serious Adverse Events at 7 days after index procedure
Measured: 7 days after index procedure
Number of Participants With 12-Month Safety Success
Success was defined as freedom from Serious Adverse Events at 12-months after index procedure
Measured: 12-months after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion31 May 2017
- Study completion31 Jul 2018
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
- Other
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- I-Med-Pro GmbH
- Responsible party
- Sponsor
- Investigators
- Gerhard Hindricks, Prof. Dr., Principal investigator, Herzzentrum Leipzig - UniversitätsklinikKristin Ruffner, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386345
- Sponsor's protocol ID
- E-FIRM 02
- Status last verified
- Jan 2020
- First submitted
- 2 Mar 2015
- Last updated
- 14 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EU Focal Impulse and Rotor Modulation Registry -Topera E-FIRM Registry-
- ClinicalTrials.gov ID
- NCT02386345
- Acronym / sponsor ID
- E-FIRM 02
- Conditions
- Atrial Fibrillation
- Keywords
- FIRM procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- I-Med-Pro GmbH
- Study start
- Mar 2015
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Posted 15 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a registry to assess the safety and effectiveness of FIRM guided procedures for the treatment of symptomatic any type of atrial fibrillation.
FIRM (Focal Impulse and Rotor Modulation) guided ablation is defined as ablating rotors identified by the FIRMap® basket catheter for visualising of rotors with the RhythmView® mapping system. In addition to the FIRM guided ablation any other ablation method could be applied.The acute success of FIRM ablations is defined as elimination of rotors defined by absence of rotors.
Data items will be collected, if available, consistent and applicable with routine and standard clinical care at each participating site.
Detailed description
Prospective and retrospective enrollment is possible.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who are receiving a FIRM guided AF ablation and are selected in accordance with the current AF guidelines are eligible for the participation in the registry
Key inclusion criteria (1 listed)
- reported incidence of at least 2 documented episodes of symptomatic AF (paroxysmal, persistent or long standing persistent) during the 3 months preceding the initial AF ablation attempt of at least one Class I or III anti-arrhythmia drug with failure defined as recurrence of symptomatic AF or adverse drug effect resulting in stopping medication
Key exclusion criteria (2 listed)
- women who are pregnant
- As this is a registry only data of patients will be included who have been treated according to the current AF guidelines.
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 Participants With Acute Success
Time frame: day of procedure
Acute Success was defined as the elimination (by ablation) of all identified rotors
Number of Participants With 12-Month Success
Time frame: 12-months after index procedure
Single procedure freedom from atrial fibrillation recurrence
Number of Participants With Acute Safety Success
Time frame: 7 days after index procedure
Acute safety success was defined as freedom from Serious Adverse Events at 7 days after index procedure
Number of Participants With 12-Month Safety Success
Time frame: 12-months after index procedure
Success was defined as freedom from Serious Adverse Events at 12-months after index procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- 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.
Gerhard Hindricks, Prof. Dr. principal investigator
Herzzentrum Leipzig - Universitätsklinik
Kristin Ruffner, PhD study director
Abbott
9 sites in 2 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 9 sites in 2 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 2 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 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Netherlands. 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 15 Oct 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 Participants With Acute Success (time frame: day of procedure). The study lists 4 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 14 Jan 2020.