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

Tracking Information
First Received Date ^ICMJE	October 26, 2010
Last Updated Date	May 2, 2013
Start Date ^ICMJE	July 2010
Estimated Primary Completion Date	July 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 26, 2010)	Freedom of atrial arrhythmias [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01229306 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 26, 2010)	Quality of life, number of reconnected pulmonary veins, safety [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Repeat Ablation Procedure in Patients With Relapse of Atrial Fibrillation
Official Title ^ICMJE	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
Brief Summary	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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Ablation Paroxysmal Atrial Fibrillation
Intervention ^ICMJE	Procedure: Ablation Ablation of atrial fibrillation
Study Arm (s)	Experimental: reisolation of all PV and additional anterior line Intervention: Procedure: Ablation Placebo Comparator: reisolation of all pulmonary veins Intervention: Procedure: Ablation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	108
Estimated Completion Date	January 2014
Estimated Primary Completion Date	July 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: relapse of atrial fibrillation Exclusion Criteria: contraindication for ablation
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01229306
Other Study ID Numbers ^ICMJE	GER-EP-002
Has Data Monitoring Committee	No
Responsible Party	Deutsches Herzzentrum München, Abteilung Elektrophysiologie
Study Sponsor ^ICMJE	Deutsches Herzzentrum Muenchen
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Deutsches Herzzentrum Muenchen
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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