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

This study is currently recruiting participants.
Verified October 2010 by Deutsches Herzzentrum Muenchen
Sponsor:
Collaborator:
Klinik für Kardiologie, Klinikum Karlsruhe, Prof. Dr. C. Schmitt
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01229033
First received: October 26, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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
Ablation
Atrial Flutter
 Procedure: Ablation
Procedure: Cardioversion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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:

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Freedom from atrial tachyarrhythmia [ Designated as safety issue: No ]
    Documented freedom from atrial tachyarrhythmia (AF or AT) during follow-up after first ablation.


Secondary Outcome Measures:
  • Procedural and safety data [ Designated as safety issue: Yes ]
    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
Estimated Study Completion Date: January 2014
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229033

Locations
Germany
Klinikum Karlsruhe Not yet recruiting
Karlsruhe, Germany, 76133
Contact: Claus Schmitt, MD            
Principal Investigator: Claus Schmitt, MD            
Deutsches Herzzentrum München Recruiting
München, Germany, 80636
Contact: Clemens Jilek, MD     +491218 ext 2020     jilek@dhm.mhn.de    
Principal Investigator: Clemens Jilek, MD            
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Klinik für Kardiologie, Klinikum Karlsruhe, Prof. Dr. C. Schmitt
Investigators
Study Chair: Isabel Deisenhofer, MD Deutsches Herzzentrum München
Principal Investigator: Clemens Jilek, MD Deutsches Herzzentrum München
  More Information

No publications provided

Responsible Party: Isabel Deisenhofer, MD and Clemens Jilek, MD, Deutsches Herzzentrum München
ClinicalTrials.gov Identifier: NCT01229033     History of Changes
Other Study ID Numbers: GE-EP-001
Study First Received: October 26, 2010
Last Updated: October 26, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Deutsches Herzzentrum Muenchen:
Atrial fibrillation
ablation
atrial flutter

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Tachycardia
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013