Topera C-FIRM Registry

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT02407249
• Lead Sponsor: Abbott Medical Devices

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

Study Timeline

• Study First Submitted: 2015-03-30
• Study First Submitted QC: 2015-03-30
• Study Start: 2015-04
• Study First Posted: 2015-04-02
• Primary Completion: 2017-05-31
• Study Completion: 2018-07-31
• Results First Submitted: 2019-09-17
• Status Verified: 2019-10
• Results First Submitted QC: 2019-10-15
• Last Update Submitted: 2019-10-15
• Results First Posted: 2019-10-16
• Last Update Posted: 2019-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Acute Success	day of procedure	Acute Success was defined as elimination (by ablation) of pulmonary vein triggers during the procedure
Number of Participants With 12-Month Safety Success	12-months after index procedure	12-Month safety success was defined as freedom from Serious Averse Events at 12-months after index procedure
Number of Participants With 12-Month Effectiveness	12 months after initial AF ablation	Effectiveness success was defined as single procedure freedom from AF recurrence at 12-months after index procedure, excluding a 3-month blanking period.
Number of Participants With Acute Safety Success	7 days after initial AF ablation	Acute safety success was defined as freedom from Serious Adverse Events 7 days after initial AF ablation

Trial Locations

Locations (9)

Kardiologische Gemeinschaftspraxis am Park Sanssouci; 🇩🇪 Potsdam, Brandenburg, Germany

Herz- und Gefäßklinik; 🇩🇪 Bad Neustadt An Der Saale, Bayern, Germany

Klinikum Coburg GmbH; 🇩🇪 Coburg, Bayern, Germany

Städtisches Klinikum Karlsruhe GmbH; 🇩🇪 Karlsruhe, Baden-Würtemberg, Germany

Herzzentrum Leipzig; 🇩🇪 Leipzig, Sachsen, Germany

Herz- und Diabeteszentrum NRW; 🇩🇪 Bad Oeynhausen, NRW, Germany

Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR; 🇩🇪 Dresden, Sachsen, Germany

Unfallkrankenhaus Berlin; 🇩🇪 Berlin, Germany

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands