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Sponsored by: |
Deutsches Herzzentrum Muenchen |
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Information provided by: | Deutsches Herzzentrum Muenchen |
ClinicalTrials.gov Identifier: | NCT00196209 |
The aim of this randomized study is to evaluate the efficacy of two different approaches for conversion of persistent atrial fibrillation, the non-invasive one (external electrical cardioversion) and the invasive one (catheter ablation).
Condition | Intervention | Phase |
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Atrial Fibrillation |
Procedure: catheter ablation Procedure: external electric cardioversion |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Study Comparing Cardioversion vs. Catheter Ablation in Patients With Persistent Atrial Fibrillation |
Estimated Enrollment: | 130 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
catheter ablation to treat persistent atrial fibrillation
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Procedure: catheter ablation
catheter ablation to treat persistent atrial fibrillation
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2: Experimental
cardioversion and drug prophylaxis to treat persistent atrial fibrillation
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Procedure: external electric cardioversion
external cardioversion and drug prophylaxis to treat persistent atrial fibrillation
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This randomized study compares two treatment strategies in patients with persistent atrial fibrillation: Cardioversion vs. catheter ablation. Cardioversion is a low risk standard treatment option for patients with persistent atrial fibrillation. However, mid- and long term efficacy (regarding the maintenance of sinus rhythm) is low. Catheter ablation is an invasive treatment which has been reported to result in up to 60-70% of patients in stable sinus rhythm. However, it is a potentially dangerous invasive procedure with potentially fatal complications.
Comparison: External cardioversion vs. catheter ablation
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Heidi L Estner, MD | 0049 89 1218 2020 | estner@dhm.mhn.de |
Germany | |
Deutsches Herzzentrum Muenchen | Recruiting |
Munich, Germany, 80636 | |
Contact: Heidi L. Estner, MD 0049 89 1218-2020 estner@dhm.mhn.de | |
Principal Investigator: Heidi L Estner, MD |
Study Chair: | Isabel Deisenhofer, MD | Deutsches Herzzentrum Muenchen |
Principal Investigator: | Heidi L Estner, MD | Deutsches Herzzentrum Muenchen |
Responsible Party: | Deutsches Herzzentrum Munich ( Prof. A. Schömig ) |
Study ID Numbers: | GE IDE No. C00705 |
Study First Received: | September 12, 2005 |
Last Updated: | March 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00196209 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
atrial fibrillation catheter ablation |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |