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Completed

NCT Number: NCT01229033

Ablating Atrial Tachycardias Occuring During Ablation of Complex Fractionated Electrograms in Persistent AF

Catheter ablation has proven to be an effective treatment option in patients suffering from symptomatic persistent atrial fibrillation (AF). Catheter ablation consists of two major steps: (1) Isolation of pulmonary veins to abolish the trigger of atrial fibrillation and (2) modification of left atrial and eventually right atrial substrate by ablation of complex fractionated atrial electrograms (CFAE). CFAE are mainly found at the ostia of the pulmonary veins, around the left atrial appendage, at the mitral annulus and the septum.

When ablating CFAE 40-65% of the patients show a regularization of AF to an atrial tachycardia (AT) that can be macro- or micro-reentrant (localized re-entry). Until now the significance of the AT is unclear.

In the following study we examine the hypothesis that an ablation of AT occuring during CFAE ablation (group 1) significantly improves outcome defined as freedom of atrial arrhythmia (AF or AT) compared to patients that are cardioverted when AF has regularized to AT (group 2).

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Karlsruhe, Karlsruhe, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients (>=18 und < 80 years) with symptomatic persistent AF (AF episode enduring at least 7 days) but are successfully convertable in sinus rhythm (SR).
  • At least one unsuccessful attempt of antiarrhythmic drug (betablocker or class I oder III).
  • Oral anticoagulation with phenprocoumone or warfarine for at least 4 weeks prior to ablation with weekly documented INR > 2..
  • Withdrawal of antiarrhythmic drugs at least 3 half times prior to ablation except amiodarone.
  • Atrial tachycardia occurring during ablation of CFAE (defined as CL > 200 msec und stable activation sequence).

Exclusion criteria

-

Treatment and study plan

Ablation

Procedure

Ablation of atrial tachycardia

Cardioversion

Procedure

Cardioversion of atrial tachycardia

Primary outcomes

  1. Freedom from atrial tachyarrhythmia

    Documented freedom from atrial tachyarrhythmia (AF or AT) during follow-up after first ablation.

Secondary outcomes

  1. Procedural and safety data

    • Duration of left atrial procedure, time of ablation, time of radiation and radiation dose from randomization until the end of the procedure.
    • In case of recurrence, characteristic of predominant tachyarrhythmia (AF or AT).
    • Safety parameters (pericardial tamponade, thrombembolic complications).
    • Number of re-ablations.

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Collaborators

  • Klinik für Kardiologie, Klinikum Karlsruhe, Prof. Dr. C. Schmitt

Registry information

Official study title

Ablating Atrial Tachycardias Occuring During Ablation of Complex Fractionated Electrograms in Persistent AF - ATTAC CFAE Trial

Acronym: ATTAC CFAE

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Oct 27, 2010
Registry last updated
Apr 11, 2017

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

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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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