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OpenTrials
Completed

NCT Number: NCT02386345

Topera E-FIRM Registry

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.

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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 is 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.

Treatment and study plan

Primary outcomes

  1. Number of Participants With Acute Success

    Time frame: day of procedure

    Acute Success was defined as the elimination (by ablation) of all identified rotors

  2. Number of Participants With 12-Month Success

    Time frame: 12-months after index procedure

    Single procedure freedom from atrial fibrillation recurrence

  3. Number of Participants With Acute Safety Success

    Time frame: 7 days after index procedure

    Acute safety success was defined as freedom from Serious Adverse Events at 7 days after index procedure

  4. Number of Participants With 12-Month Safety Success

    Time frame: 12-months after index procedure

    Success was defined as freedom from Serious Adverse 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

    Success was defined as freedom from Serious Adverse Events at 6-months after index procedure

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Collaborators

  • I-Med-Pro GmbH

Registry information

Official study title

EU Focal Impulse and Rotor Modulation Registry -Topera E-FIRM Registry-

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Mar 11, 2015
Registry last updated
Jan 14, 2020

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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