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Sponsors and Collaborators: |
German Atrial Fibrillation Network Bard Biosense Webster, Inc. St. Jude Medical Medtronic |
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Information provided by: | German Atrial Fibrillation Network |
ClinicalTrials.gov Identifier: | NCT00293943 |
The purpose of this study is to investigate the significance of complete versus incomplete electrical isolation of pulmonary veins by radiofrequency-induced linear lesions in patients with paroxysmal atrial fibrillation.
The study hypothesis ist that the complete linear PV isolation ablation is superior to the non-complete linear PV isolation on the outcome of patients with idiopathic drug-refractory atrial fibrillation. As a second hypothesis in this adaptive study design, the non-inferiority of the complete linear PV isolation strategy will be tested.
Condition | Intervention |
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Atrial Fibrillation |
Procedure: Pulmonary vein ablation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Trial to Investigate the Significance of Complete Versus Incomplete Electrical Isolation of Pulmonary Veins by Radiofrequency-Induced Linear Lesions |
Estimated Enrollment: | 192 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | August 2008 |
Ages Eligible for Study: | 50 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stephan Willems, MD | +49-(0)40-42803 ext 4120 | willems@uke.uni-hamburg.de |
Contact: Sabine Ernst, MD | +49-(0)40-181885 ext 2305 | SErnst1708@aol.com |
Germany | |
University Cardiac Center | Recruiting |
Hamburg, Germany, 20246 | |
Contact: Stephan Willems, MD +49-(0)40-42803 ext 4120 willems@uke.uni-hamburg.de | |
Contact: Boris A Lutomsky, MD +49-(0)40-42803 ext 4733 lutomsky@uke.uni-hamburg.de | |
General Hospital St. Georg, Department of Cardiology | Recruiting |
Hamburg, Germany, 20099 | |
Contact: Karl H Kuck, MD +49-(0)40-181885 ext 2305 Karl_Heinz.Kuck@ak-stgeorg.lbk-hh.de | |
Contact: Sabine Ernst, MD +49-(0)40-181885 ext 2305 SErnst1708@aol.com | |
University Hospital, Department of Cardiology | Recruiting |
MÜNSTER, Germany, 48149 | |
Contact: Günter Breithardt, MD +49-(0)251-834 ext 7617 g.breithardt@uni-muenster.de | |
Contact: Lars Eckhardt, MD +49-(0)251-834 ext 7687 l.eckardt@uni-muenster.de |
Principal Investigator: | Günter Breithardt, MD | University of Münster |
Principal Investigator: | Karl-Heinz Kuck, MD | General Hospital St. Georg, Hamburg |
Principal Investigator: | Stephan Willems, MD | Universitätsklinikum Hamburg-Eppendorf |
Study ID Numbers: | AFNET-B04-1 |
Study First Received: | February 17, 2006 |
Last Updated: | February 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00293943 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Atrial fibrillation Pulmonary vein ablation Linear lesions |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |