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Completed

NCT Number: NCT02407249

Topera C-FIRM Registry

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Städtisches Klinikum Karlsruhe GmbH, Karlsruhe, Baden-Würtemberg, Germany

Loading trial locations.

About this study

Prospective and retrospective enrollment possible

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of Participants With Acute Success

    Time frame: day of procedure

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

  2. Number of Participants With 12-Month Effectiveness

    Time frame: 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.

  3. Number of Participants With Acute Safety Success

    Time frame: 7 days after initial AF ablation

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

  4. Number of Participants With 12-Month Safety Success

    Time frame: 12-months after index procedure

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

Other outcomes

  1. Number of Participants With 6-month Safety Success

    Time frame: 6-months after index procedure

    6-Month safety success was defined as freedom from Serious Adverse Events 6-months after index procedure

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Collaborators

  • I-Med-Pro GmbH

Registry information

Official study title

Control for EU (European Union) Focal Impulse and Rotor Modulation Registry - Topera C-FIRM Registry-

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Apr 2, 2015
Registry last updated
Oct 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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