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Sponsored by: |
Deutsches Herzzentrum Muenchen |
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Information provided by: | Deutsches Herzzentrum Muenchen |
ClinicalTrials.gov Identifier: | NCT00196157 |
In this randomized study dealing with the ablative treatment of persistent atrial fibrillation, two ablation strategies are compared: A more anatomically guided linear ablation scheme versus an electrophysiological guided focal ablation strategy aiming at the electrical isolating of the pulmonary veins and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.
Condition | Intervention | Phase |
---|---|---|
Atrial Fibrillation |
Procedure: linear anatomically oriented ablations Procedure: focal electrophysiological oriented ablations |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Linear Anatomically Versus Focal Electrophysiologically Guided Substrate Ablation in Patients With Persistent Atrial Fibrillation |
Estimated Enrollment: | 116 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
linear lesions to ablate persistent atrial fibrillation
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Procedure: linear anatomically oriented ablations
linear lesions to ablate persistent atrial fibrillation
|
2: Experimental
focal electrophysiologically guided ablations to treat persistent atrial fibrillation
|
Procedure: focal electrophysiological oriented ablations
focal electrophysiologically guided ablations to treat persistent atrial fibrillation
|
This randomized study deals with two different ablative treatment strategies for persistent atrial fibrillation: A more anatomically guided linear ablation scheme with encircling of the ipsilateral pulmonary veins (PV), a left atrial roof line and an anterior line bridging the anterior mitral anulus to the ostium of the left superior PV versus an electrophysiological guided focal ablation strategy aiming at isolating electrically the PV and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.
Both ablation approaches contain isolation of the most common source of triggering foci, i.e. the pulmonary veins and additional modification of the substrate maintaining atrial fibrillation.
The study endpoint is a combined efficacy/safety analysis. Extensive follow-up with three-monthly 7 days holter ECG is provided.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Heidi Estner, MD | 0049 89 1218 2020 | estner@dhm.mhn.de |
Germany | |
Deutsches Herzzentrum Muenchen | Recruiting |
Munich, Germany, 80636 | |
Contact: Heidi Estner, MD 0049 89 1218 2020 estner@dhm.mhn.de | |
Principal Investigator: Heidi Estner, MD |
Study Chair: | Claus Schmitt, MD | Deutsches Herzzentrum Muenchen |
Principal Investigator: | Heidi Estner, MD | Deutsches Herzzentrum Muenchen |
Responsible Party: | Deutsches Herzzentrum Munich ( Prof. A. Schömig ) |
Study ID Numbers: | GE IDE No. C00604 |
Study First Received: | September 12, 2005 |
Last Updated: | March 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00196157 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |