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

This study is currently recruiting participants.
Verified February 2013 by Deutsches Herzzentrum Muenchen
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01229475
First received: October 26, 2010
Last updated: February 28, 2013
Last verified: February 2013

October 26, 2010
February 28, 2013
October 2010
October 2013   (final data collection date for primary outcome measure)
Freedom from atrial arrhythmia [ Designated as safety issue: No ]
Documented freedom from atrial arrhythmia (AF or AT) during follow-up.
Same as current
Complete list of historical versions of study NCT01229475 on ClinicalTrials.gov Archive Site
Procedural and safety data [ Designated as safety issue: Yes ]
  1. Duration of left atrial procedure, ablation time, fluoroscopy time.
  2. Complications
  3. Type of recurrent arrhythmia
  4. Number of reablation
Same as current
Not Provided
Not Provided
 
Stepwise Approach Versus Linear Ablation in Patients With Recurrence of Persistent Atrial Fibrillation
Stepwise Approach Versus Linear Ablation for Repeat Procedure in Patients With Recurrence of Persistent Atrial Fibrillation

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Recurrence
  • Procedure: Ablation with stepwise approach
    Stepwise approach for repeat AF ablation
  • Procedure: Linear ablation
    Linear ablation for AF ablation
  • Active Comparator: Stepwise approach
    Stepwise approach for repeat AF ablation
    Interventions:
    • Procedure: Ablation with stepwise approach
    • Procedure: Linear ablation
  • Active Comparator: Linear ablation
    Linear ablation for repeat procedure in patients with recurrent atrial fibrillation
    Interventions:
    • Procedure: Ablation with stepwise approach
    • Procedure: Linear ablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
December 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Sonia Ammar, MD +49891218 ext 2020 ammar@dhm.mhn.de
Germany
 
NCT01229475
GER-EP-003
No
Isabel Deisenhofer, MD and Sonia Ammar, MD, Deutsches Herzzentrum München
Deutsches Herzzentrum Muenchen
Not Provided
Study Chair: Isabel Deisenhofer, MD Deutsches Herzzentrum München
Principal Investigator: Sonia Ammar, MD Deutsches Herzzentrum München
Deutsches Herzzentrum Muenchen
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP