Text Size

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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

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


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 26, 2010
Last Updated: February 28, 2013
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 23, 2013