Clinical trial NCT02386345: Topera E-FIRM Registry
Official title: EU Focal Impulse and Rotor Modulation Registry -Topera E-FIRM Registry-
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: FIRM procedure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: I-Med-Pro GmbH
First posted: 2015-03-11
Enrollment: 299
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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.

Primary outcomes:
measure: Number of Participants With Acute Success
timeFrame: day of procedure
measure: Number of Participants With 12-Month Success
timeFrame: 12-months after index procedure
measure: Number of Participants With Acute Safety Success
timeFrame: 7 days after index procedure
measure: Number of Participants With 12-Month Safety Success
timeFrame: 12-months after index procedure
Secondary outcomes:
Other outcomes:
measure: Number of Participants With 6-Month Safety Success
timeFrame: 6-months after index procedure
Locations:
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe GmbH
state: Baden-Würtemberg
city: Bad Neustadt An Der Saale
country: Germany
facility: Herz- und Gefäßklinik
state: Bayern
city: Coburg
country: Germany
facility: Klinikum Coburg GmbH
state: Bayern
city: Potsdam
country: Germany
facility: Kardiologische Gemeinschaftspraxis am Park Sanssouci
state: Brandenburg
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
state: NRW
city: Dresden
country: Germany
facility: Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR
state: Sachsen
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
state: Sachsen
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: Herzzentrum Leipzig - Universitätsklinik
name: Gerhard Hindricks, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Abbott
name: Kristin Ruffner, PhD
role: STUDY_DIRECTOR
References: