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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014