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Ablating Atrial Tachycardias Occuring During Ablation of Complex Fractionated Electrograms in Persistent AF (ATTAC CFAE)

This study has been completed.
Klinik für Kardiologie, Klinikum Karlsruhe, Prof. Dr. C. Schmitt
Information provided by:
Deutsches Herzzentrum Muenchen Identifier:
First received: October 26, 2010
Last updated: April 10, 2017
Last verified: April 2017

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).

Condition Intervention
Atrial Fibrillation
Atrial Flutter
Procedure: Ablation
Procedure: Cardioversion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Ablating Atrial Tachycardias Occuring During Ablation of Complex Fractionated Electrograms in Persistent AF - ATTAC CFAE Trial

Resource links provided by NLM:

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Freedom from atrial tachyarrhythmia
    Documented freedom from atrial tachyarrhythmia (AF or AT) during follow-up after first ablation.

Secondary Outcome Measures:
  • Procedural and safety data
    1. Duration of left atrial procedure, time of ablation, time of radiation and radiation dose from randomization until the end of the procedure.
    2. In case of recurrence, characteristic of predominant tachyarrhythmia (AF or AT).
    3. Safety parameters (pericardial tamponade, thrombembolic complications).
    4. Number of re-ablations.

Estimated Enrollment: 186
Study Start Date: January 2010
Study Completion Date: January 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ablation
Ablation of atrial tachycardia
Procedure: Ablation
Ablation of atrial tachycardia
Active Comparator: Cardioversion
Cardioversion of atrial tachycardia
Procedure: Cardioversion
Cardioversion of atrial tachycardia


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

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Please refer to this study by its identifier: NCT01229033

Klinikum Karlsruhe
Karlsruhe, Germany, 76133
Deutsches Herzzentrum München
München, Germany, 80636
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Klinik für Kardiologie, Klinikum Karlsruhe, Prof. Dr. C. Schmitt
Study Chair: Isabel Deisenhofer, MD Deutsches Herzzentrum München
Principal Investigator: Clemens Jilek, MD Deutsches Herzzentrum München
  More Information

Responsible Party: Isabel Deisenhofer, MD and Clemens Jilek, MD, Deutsches Herzzentrum München Identifier: NCT01229033     History of Changes
Other Study ID Numbers: GER-EP-001
Study First Received: October 26, 2010
Last Updated: April 10, 2017

Keywords provided by Deutsches Herzzentrum Muenchen:
Atrial fibrillation
atrial flutter

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on April 28, 2017