Repeat Ablation Procedure in Patients With Relapse of Atrial Fibrillation
Primary Purpose
Ablation, Paroxysmal Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Ablation
Eligibility Criteria
Inclusion Criteria:
- relapse of atrial fibrillation
Exclusion Criteria:
- contraindication for ablation
Sites / Locations
- Deutsches HerzzentrumRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
reisolation of all PV and additional anterior line
reisolation of all pulmonary veins
Arm Description
Outcomes
Primary Outcome Measures
Freedom of atrial arrhythmias
Secondary Outcome Measures
Quality of life, number of reconnected pulmonary veins, safety
Full Information
NCT ID
NCT01229306
First Posted
October 26, 2010
Last Updated
May 2, 2013
Sponsor
Deutsches Herzzentrum Muenchen
1. Study Identification
Unique Protocol Identification Number
NCT01229306
Brief Title
Repeat Ablation Procedure in Patients With Relapse of Atrial Fibrillation
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
January 2014 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Deutsches Herzzentrum Muenchen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ablation, Paroxysmal Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
reisolation of all PV and additional anterior line
Arm Type
Experimental
Arm Title
reisolation of all pulmonary veins
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Ablation
Intervention Description
Ablation of atrial fibrillation
Primary Outcome Measure Information:
Title
Freedom of atrial arrhythmias
Secondary Outcome Measure Information:
Title
Quality of life, number of reconnected pulmonary veins, safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
relapse of atrial fibrillation
Exclusion Criteria:
contraindication for ablation
Facility Information:
Facility Name
Deutsches Herzzentrum
City
München
State/Province
Bayer
ZIP/Postal Code
80636
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel Deisenhofer, MD
Phone
+49891218
Ext
4596
Email
deisenhofer@dhm.mhn.de
First Name & Middle Initial & Last Name & Degree
Stephanie Fichtner, MD
Phone
+49891218
Ext
4596
Email
fichtner@dhm.mhn.de
First Name & Middle Initial & Last Name & Degree
Isabel Deisenhofer, MD
12. IPD Sharing Statement
Learn more about this trial
Repeat Ablation Procedure in Patients With Relapse of Atrial Fibrillation
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