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Atrial FibrillationNCT02386345

Topera E-FIRM Registry

An observational study of Atrial Fibrillation, run by Abbott Medical Devices at 9 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Germany

Netherlands1 site

  • Erasmus Medical Center

    Rotterdam, 3015

Other trials in Netherlands

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.

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.

  1. Number of Participants With Acute Success

    Acute Success was defined as the elimination (by ablation) of all identified rotors

    Measured: day of procedure

  2. Number of Participants With 12-Month Success

    Single procedure freedom from atrial fibrillation recurrence

    Measured: 12-months after index procedure

  3. 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

  4. 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.

  1. First posted11 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completion31 May 2017
  4. Study completion31 Jul 2018

Resources

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)
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
Data monitoring committee
No

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?

On the ClinicalTrials.gov record for NCT02386345.

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.

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