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

October 26, 2010
May 2, 2013
July 2010
July 2013   (final data collection date for primary outcome measure)
Freedom of atrial arrhythmias [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01229306 on ClinicalTrials.gov Archive Site
Quality of life, number of reconnected pulmonary veins, safety [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Repeat Ablation Procedure in Patients With Relapse of Atrial Fibrillation
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ablation
  • Paroxysmal Atrial Fibrillation
Procedure: Ablation
Ablation of atrial fibrillation
  • Experimental: reisolation of all PV and additional anterior line
    Intervention: Procedure: Ablation
  • Placebo Comparator: reisolation of all pulmonary veins
    Intervention: Procedure: Ablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
108
January 2014
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • relapse of atrial fibrillation

Exclusion Criteria:

  • contraindication for ablation
Both
18 Years to 80 Years
No
Not Provided
Germany
 
NCT01229306
GER-EP-002
No
Deutsches Herzzentrum München, Abteilung Elektrophysiologie
Deutsches Herzzentrum Muenchen
Not Provided
Not Provided
Deutsches Herzzentrum Muenchen
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP