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Line Versus Spot Ablation in Persistent Atrial Fibrillation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Deutsches Herzzentrum Muenchen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00196157
First received: September 12, 2005
Last updated: May 28, 2009
Last verified: May 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Sinus rhythm in follow-up [ Time Frame: Sinus rhythm in follow-up ] [ Designated as safety issue: No ]

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

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

No publications provided

Responsible Party: Prof. A. Schömig, Deutsches Herzzentrum Munich
ClinicalTrials.gov Identifier: NCT00196157     History of Changes
Other Study ID Numbers: GE IDE No. C00604
Study First Received: September 12, 2005
Last Updated: May 28, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 16, 2013