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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
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ablation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 26, 2010
Last Updated
May 2, 2013
Sponsor
Deutsches Herzzentrum Muenchen
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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

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Repeat Ablation Procedure in Patients With Relapse of Atrial Fibrillation

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