Stepwise Approach Versus Linear Ablation in Patients With Recurrence of Persistent Atrial Fibrillation - Full Text View

Sponsor:	Deutsches Herzzentrum Muenchen
Information provided by:	Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:	NCT01229475

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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation

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:	October 2013
Estimated Primary Completion Date:	October 2012 (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-EP003
Study First Received:	October 26, 2010
Last Updated:	October 26, 2010
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, 2012