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NCT01229306 Clinical Trial

Repeat Ablation Procedure in Patients With Relapse of Atrial Fibrillation

Paroxysmal Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01229306
Other study ID # GER-EP-002
Secondary ID
Status Recruiting
Phase N/A
First received October 26, 2010
Last updated May 2, 2013
Start date July 2010
Est. completion date January 2014

Study information
Verified date May 2013
Source Deutsches Herzzentrum Muenchen
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Comission
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 108
Est. completion date January 2014
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- relapse of atrial fibrillation

Exclusion Criteria:

- contraindication for ablation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Ablation
Ablation of atrial fibrillation

Locations
Country Name City State
Germany Deutsches Herzzentrum München Bayer

Sponsors (1)
Lead Sponsor Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Freedom of atrial arrhythmias No
Secondary Quality of life, number of reconnected pulmonary veins, safety Yes
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