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Line Versus Spot Ablation in Persistent Atrial Fibrillation

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 May 2009 by Deutsches Herzzentrum Muenchen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00196157
First Posted: September 20, 2005
Last Update Posted: May 29, 2009
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
In this randomized study dealing with the ablative treatment of persistent atrial fibrillation, two ablation strategies are compared: a more anatomically guided linear ablation scheme versus an electrophysiological guided focal ablation strategy aiming at the electrical isolating of the pulmonary veins and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.

Condition Intervention Phase
Atrial Fibrillation Procedure: linear anatomically oriented ablations Procedure: focal electrophysiological oriented ablations Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Linear Anatomically Versus Focal Electrophysiologically Guided Substrate Ablation in Patients With Persistent Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Sinus rhythm in follow-up [ Time Frame: Sinus rhythm in follow-up ]

Estimated Enrollment: 116
Study Start Date: August 2004
Estimated Study Completion Date: November 2008
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
linear lesions to ablate persistent atrial fibrillation
Procedure: linear anatomically oriented ablations
linear lesions to ablate persistent atrial fibrillation
Experimental: 2
focal electrophysiologically guided ablations to treat persistent atrial fibrillation
Procedure: focal electrophysiological oriented ablations
focal electrophysiologically guided ablations to treat persistent atrial fibrillation

Detailed Description:

This randomized study deals with two different ablative treatment strategies for persistent atrial fibrillation: a more anatomically guided linear ablation scheme with encircling of the ipsilateral pulmonary veins (PV), a left atrial roof line and an anterior line bridging the anterior mitral anulus to the ostium of the left superior PV versus an electrophysiological guided focal ablation strategy aiming at isolating, electrically, the PV and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.

Both ablation approaches contain isolation of the most common source of triggering foci, i.e., the pulmonary veins and additional modification of the substrate maintaining atrial fibrillation.

The study endpoint is a combined efficacy/safety analysis. Extensive follow-up with three-monthly 7 days holter ECG is provided.

  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:

  • age between 18 and 80 years
  • symptomatic persistent (> 7 days lasting) atrial fibrillation
  • at least one unsuccessful cardioversion or atrial fibrillation relapse in the first 3 months after cardioversion despite antiarrhythmic drug therapy
  • oral anticoagulation (> 4 weeks prior to ablation)

Exclusion Criteria:

  • moderate to severe valvular heart disease
  • congenital heart disease
  • LV-EF < 35%
  • reversible cause for atrial fibrillation (e.g., hyperthyreosis)
  • prior left atrial ablation or Maze operation
  • left atrial 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): NCT00196157


Contacts
Contact: Heidi Estner, MD 0049 89 1218 2020 estner@dhm.mhn.de

Locations
Germany
Deutsches Herzzentrum Muenchen Recruiting
Munich, Germany, 80636
Contact: Heidi Estner, MD    0049 89 1218 2020    estner@dhm.mhn.de   
Principal Investigator: Heidi Estner, MD         
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Study Chair: Claus Schmitt, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Heidi Estner, MD Deutsches Herzzentrum Muenchen
  More Information

Responsible Party: Prof. A. Schömig, Deutsches Herzzentrum Munich
ClinicalTrials.gov Identifier: NCT00196157     History of Changes
Other Study ID Numbers: GE IDE No. C00604
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: May 29, 2009
Last Verified: May 2009

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