Catheter Ablation Versus Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00296166|
Recruitment Status : Terminated (Patients with permanent AF are seldomly symptomatic enough to justify intervention. We decided to stop inclusion due to low recruitment rate.)
First Posted : February 24, 2006
Last Update Posted : September 2, 2010
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 or disease||Intervention/treatment|
|Atrial Fibrillation||Procedure: Catheter ablation Procedure: Thoracoscopic epicardial ablation|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||November 2006|
|Estimated Study Completion Date :||November 2010|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296166
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Jesper H Svendsen, MD||Rigshospitalet, Denmark|