Catheter Ablation Versus Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation
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.
Procedure: Catheter ablation
Procedure: Thoracoscopic epicardial ablation
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Presence of sinus rhythm [ Time Frame: after 6 months from treatment ]
- complications [ Time Frame: during 12 months from treatment ]
- cost-effectiveness [ Time Frame: during 12 months from treatment ]
- structural changes (evaluated by echocardiography) [ Time Frame: during 12 months from treatment ]
- p-BNP [ Time Frame: during 12 months from treatment ]
- inflammatory markers [ Time Frame: during 12 months from treatment ]
- atrial fibrillation burden evaluated by Holter monitoring [ Time Frame: at 6 months from treatment ]
- exercise performance [ Time Frame: at 3 months from treatment ]
- Quality of life [ Time Frame: at 3 months from treatment ]
|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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296166
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Jesper H Svendsen, MD||Rigshospitalet, Denmark|