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Sponsored by: |
Rigshospitalet, Denmark |
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Information provided by: | Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00296166 |
Patents with atrial fibrillation can be treated with the purpose of curing the arrhythmia.This may be achieved by catheter ablation and Maze surgery where the latter includes open heart surgery. By catheter ablation the arrhythmia can be cured in about 70 % of patients who have episodes of atrial fibrillation. In patients with permanent atrial fibrillation the results are not as good. We will compare a conventional ablation approach where lesions are created on the inside of the heart with a thoracoscopic approach where the lesions are created from the outside of the heart.
Condition | Intervention |
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Atrial Fibrillation |
Procedure: Catheter ablation Procedure: Thoracoscopic epicardial ablation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Study That Will Show the Effects of Catheter Ablation Compared to the Effects of Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation. |
Estimated Enrollment: | 200 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | November 2010 |
Patients with permanent atrial fibrillation will be considered for randomisation Patients will be randomised to either conventional endocardial catheter ablation or epicardial thoracoscopic ablation.
Objectives of study:
Primary endpoint:presence of sinus rhythm after 6 months Secondary endpoints: complications, cost-effectiveness, structural changes (evaluated by echocardiography), p-BNP and inflammatory markers, atrial fibrillation burden evaluated by Holter monitoring
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jesper H Svendsen, MD | (45) 35452817 | hastrup@rh.dk |
Contact: Daniel Steinbrückel, MD | (45) 35458016 |
Denmark | |
Risghospitalet, | Recruiting |
Copenhagen, Denmark, 2100 | |
Contact: Xu Chen 3545 2817 | |
Contact: Jens Lund, MD 3545 1099 | |
Sub-Investigator: Steen Pehrson, MD | |
Sub-Investigator: Helen H Petersen, MD | |
Sub-Investigator: Xu Chen, MD | |
Sub-Investigator: Jens Lund, `MD |
Principal Investigator: | Jesper H Svendsen, MD | Rigshospitalet, Denmark |
Study ID Numbers: | KAT-SKOPI study, KF - 01-284215 |
Study First Received: | February 23, 2006 |
Last Updated: | September 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00296166 History of Changes |
Health Authority: | Denmark: Ethics Committee |
Atrial fibrillation Permanent Atrial fibrillation catheter ablation |
thoracoscopy Arrhythmia Heart |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Heart Diseases Cardiovascular Diseases Atrial Fibrillation Arrhythmias, Cardiac |