- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01229306
Repeat Ablation Procedure in Patients With Relapse of Atrial Fibrillation
May 2, 2013 updated by: Deutsches Herzzentrum Muenchen
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bayer
-
München, Bayer, Germany, 80636
- Recruiting
- Deutsches Herzzentrum
-
Contact:
- Isabel Deisenhofer, MD
- Phone Number: 4596 +49891218
- Email: deisenhofer@dhm.mhn.de
-
Contact:
- Stephanie Fichtner, MD
- Phone Number: 4596 +49891218
- Email: fichtner@dhm.mhn.de
-
Principal Investigator:
- Isabel Deisenhofer, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- relapse of atrial fibrillation
Exclusion Criteria:
- contraindication for ablation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: reisolation of all PV and additional anterior line
|
Ablation of atrial fibrillation
|
Placebo Comparator: reisolation of all pulmonary veins
|
Ablation of atrial fibrillation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Freedom of atrial arrhythmias
|
Secondary Outcome Measures
Outcome Measure |
---|
Quality of life, number of reconnected pulmonary veins, safety
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Anticipated)
July 1, 2013
Study Completion (Anticipated)
January 1, 2014
Study Registration Dates
First Submitted
October 26, 2010
First Submitted That Met QC Criteria
October 26, 2010
First Posted (Estimate)
October 27, 2010
Study Record Updates
Last Update Posted (Estimate)
May 3, 2013
Last Update Submitted That Met QC Criteria
May 2, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GER-EP-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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