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Repeat Ablation Procedure in Patients With Relapse of Atrial Fibrillation

This study is currently recruiting participants.
Verified May 2013 by Deutsches Herzzentrum Muenchen
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01229306
First received: October 26, 2010
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

Catheter ablation with isolation of the pulmonary veins has proven to be an effective treatment option in patients with paroxysmal atrial fibrillation. In patients who have a relapse of paroxysmal atrial fibrillation after one ablation procedure the investigators compare the reisolation of all pulmonary veins to reisolation plus an anterior left atrial line.


Condition Intervention
Ablation
Paroxysmal Atrial Fibrillation
 Procedure: 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: Repeat Ablation Procedure in Patients With Relapse of Paroxysmal Atrial Fibrillation Using Reisolation of Pulmonary Vein Versus Reisolation of Pulmonary Vein With Additional Anterior Line

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Freedom of atrial arrhythmias [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life, number of reconnected pulmonary veins, safety [ Designated as safety issue: Yes ]

Estimated Enrollment: 108
Study Start Date: July 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: reisolation of all PV and additional anterior line Procedure: Ablation
Ablation of atrial fibrillation
Placebo Comparator: reisolation of all pulmonary veins Procedure: Ablation
Ablation of atrial fibrillation

Detailed Description:

Catheter ablation with isolation of the pulmonary veins has proven to be an effective treatment option in patients with paroxysmal atrial fibrillation. In patients who have a relapse of paroxysmal atrial fibrillation after one ablation procedure we compare the reisolation of all pulmonary veins to reisolation plus an anterior left atrial line.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • relapse of atrial fibrillation

Exclusion Criteria:

  • contraindication for ablation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229306

Locations
Germany
Deutsches Herzzentrum Recruiting
München, Bayer, Germany, 80636
Contact: Isabel Deisenhofer, MD     +49891218 ext 4596     deisenhofer@dhm.mhn.de    
Contact: Stephanie Fichtner, MD     +49891218 ext 4596     fichtner@dhm.mhn.de    
Principal Investigator: Isabel Deisenhofer, MD            
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
  More Information

No publications provided

Responsible Party: Deutsches Herzzentrum München, Abteilung Elektrophysiologie
ClinicalTrials.gov Identifier: NCT01229306     History of Changes
Other Study ID Numbers: GER-EP-002
Study First Received: October 26, 2010
Last Updated: May 2, 2013
Health Authority: Germany: Ethics Comission

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

ClinicalTrials.gov processed this record on June 13, 2013