Topera C-FIRM Registry

Abbott Medical Devices73 enrolled

Overview

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.

Prospective and retrospective enrollment possible

Study Type

OBSERVATIONAL

Enrollment

Conditions

Atrial Fibrillation

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (9)

Städtisches Klinikum Karlsruhe GmbH

Karlsruhe, Baden-Würtemberg, Germany

Herz- und Gefäßklinik

Bad Neustadt an der Saale, Bavaria, Germany

Klinikum Coburg GmbH

Coburg, Bavaria, Germany

Kardiologische Gemeinschaftspraxis am Park Sanssouci

Outcomes

Primary Outcomes

Number of Participants With Acute Success

Acute Success was defined as elimination (by ablation) of pulmonary vein triggers during the procedure

Time frame: day of procedure

Number of Participants With 12-Month Effectiveness

Effectiveness success was defined as single procedure freedom from AF recurrence at 12-months after index procedure, excluding a 3-month blanking period.

Time frame: 12 months after initial AF ablation

Number of Participants With Acute Safety Success

Acute safety success was defined as freedom from Serious Adverse Events 7 days after initial AF ablation

Time frame: 7 days after initial AF ablation

Number of Participants With 12-Month Safety Success

12-Month safety success was defined as freedom from Serious Averse Events at 12-months after index procedure

Time frame: 12-months after index procedure

Data from ClinicalTrials.gov

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