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Stepwise Approach Versus Linear Ablation in Patients With Recurrence of Persistent Atrial Fibrillation (REDO-AF)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Deutsches Herzzentrum Muenchen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01229475
First Posted: October 27, 2010
Last Update Posted: March 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Deutsches Herzzentrum Muenchen
  Purpose

Catheter ablation of persistent atrial fibrillation (AF) remains a challenging procedure. Even in experienced centres, repeat interventions are necessary in up to 70 of patients to achieve sinus rhythm at a long-term follow-up.

While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for the ablation of paroxysmal and persistent AF ablation, different additional ablation strategies are used to achieve a modification of the substrate that perpetuates the arrhythmia: linear lesions (anterior and roof lines) or ablation of complex fractionated atrial electrograms (CFAE). In the stepwise approach PVI, CFAE ablation and/or LL are combined according to the presenting arrhythmia during procedure.

The aim of the study is to determine whether there is a difference in terms of freedom from arrhythmia between a stepwise approach and a linear ablation for repeat procedure in patient with recurrence of persistent atrial fibrillation.


Condition Intervention
Atrial Fibrillation Recurrence Procedure: Ablation with stepwise approach Procedure: Linear ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stepwise Approach Versus Linear Ablation for Repeat Procedure in Patients With Recurrence of Persistent Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

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


Secondary Outcome Measures:
  • Procedural and safety data
    1. Duration of left atrial procedure, ablation time, fluoroscopy time.
    2. Complications
    3. Type of recurrent arrhythmia
    4. Number of reablation


Estimated Enrollment: 130
Study Start Date: October 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stepwise approach
Stepwise approach for repeat AF ablation
Procedure: Ablation with stepwise approach
Stepwise approach for repeat AF ablation
Procedure: Linear ablation
Linear ablation for AF ablation
Active Comparator: Linear ablation
Linear ablation for repeat procedure in patients with recurrent atrial fibrillation
Procedure: Ablation with stepwise approach
Stepwise approach for repeat AF ablation
Procedure: Linear ablation
Linear ablation for AF ablation

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients with recurrence of symptomatic persistent atrial fibrillation after at least one ablation procedure,
  • with the last ablation procedure at least 3 months ago.
  • at least one unsuccessful attempt of antiarrhythmic drug
  • oral anticoagulation for at least 4 weeks prior to ablation

Exclusion Criteria:

  • LA thrombus
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229475


Contacts
Contact: Sonia Ammar, MD +49891218 ext 2020 ammar@dhm.mhn.de

Locations
Germany
Deutsches Herzzentrum München Recruiting
Munich, Germany, 80636
Principal Investigator: Sonia Ammar, MD         
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Study Chair: Isabel Deisenhofer, MD Deutsches Herzzentrum München
Principal Investigator: Sonia Ammar, MD Deutsches Herzzentrum München
  More Information

Responsible Party: Isabel Deisenhofer, MD and Sonia Ammar, MD, Deutsches Herzzentrum München
ClinicalTrials.gov Identifier: NCT01229475     History of Changes
Other Study ID Numbers: GER-EP-003
First Submitted: October 26, 2010
First Posted: October 27, 2010
Last Update Posted: March 1, 2013
Last Verified: February 2013

Keywords provided by Deutsches Herzzentrum Muenchen:
Atrial fibrillation
recurrence
repeat procedure
linear ablation
stepwise approach

Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes