Clinical trial NCT02407249: Topera C-FIRM Registry
Official title: Control for EU (European Union) Focal Impulse and Rotor Modulation Registry - Topera C-FIRM Registry-
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: I-Med-Pro GmbH
First posted: 2015-04-02
Enrollment: 73
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: Each participating site will enroll 10 consecutive conventional AF patients who are treated according to the standard routine of the center. Patients eligible should be in accordance with the AF Guidelines.

Brief summary: This is a control registry to the E-FIRM registry to track conventional atrial fibrillation (AF) procedures in terms of clinical usage, handling, and the safety and effectiveness for the treatment of symptomatic atrial fibrillation. Conventional AF ablation is defined as pulmonary vein isolation (PVI) and any additional ablation for AF according to the standard routine of the center.

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 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 and the daily routine of the center.

Primary outcomes:
measure: Number of Participants With Acute Success
timeFrame: day of procedure
measure: Number of Participants With 12-Month Effectiveness
timeFrame: 12 months after initial AF ablation
measure: Number of Participants With Acute Safety Success
timeFrame: 7 days after initial AF ablation
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: