Topera E-FIRM Registry
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT02386345
- Lead Sponsor
- Abbott Medical Devices
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 299
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
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With 12-Month Success 12-months after index procedure Single procedure freedom from atrial fibrillation recurrence
Number of Participants With Acute Success day of procedure Acute Success was defined as the elimination (by ablation) of all identified rotors
Number of Participants With Acute Safety Success 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 12-months after index procedure Success was defined as freedom from Serious Adverse Events at 12-months after index procedure
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Kardiologische Gemeinschaftspraxis am Park Sanssouci
🇩🇪Potsdam, Brandenburg, Germany
Herz- und Gefäßklinik
🇩🇪Bad Neustadt An Der Saale, Bayern, Germany
Städtisches Klinikum Karlsruhe GmbH
🇩🇪Karlsruhe, Baden-Würtemberg, Germany
Klinikum Coburg GmbH
🇩🇪Coburg, Bayern, Germany
Herzzentrum Leipzig
🇩🇪Leipzig, Sachsen, Germany
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR
🇩🇪Dresden, Sachsen, Germany
Herz- und Diabeteszentrum NRW
🇩🇪Bad Oeynhausen, NRW, Germany
Unfallkrankenhaus Berlin
🇩🇪Berlin, Germany