Catheter Ablation Versus Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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A Randomized Study That Will Show the Effects of Catheter Ablation Compared to the Effects of Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation.

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Catheter ablation
* Procedure: Thoracoscopic epicardial ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Permanent atrial fibrillation documented on at least 2 ecg´s with more than 1 month between ecg´s. The diagnosis is verified on Holter. All patients have symptoms or do not tolerate rate control treatment. Exclusion Criteria: Psychiatric disease or suspicion of incapability to give informed concent Females with birth giving potential Previous heart surgery Previous ablation for atrial fibrillation Life expectance less than 1 year Congenital heart disease Expected need for heart surgery Heart failure (NYHA class IV) Inability to be treated with anticoagulation In case of previous deep venous thromboembolism og stroke the investigators will individually consider if the patient is suitable for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Catheter ablation|nan|
|Procedure: Thoracoscopic epicardial ablation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of sinus rhythm |  | after 6 months from treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications |  | during 12 months from treatment | 
| cost-effectiveness |  | during 12 months from treatment | 
| structural changes (evaluated by echocardiography) |  | during 12 months from treatment | 
| p-BNP |  | during 12 months from treatment | 
| inflammatory markers |  | during 12 months from treatment | 
| atrial fibrillation burden evaluated by Holter monitoring |  | at 6 months from treatment | 
| exercise performance |  | at 3 months from treatment | 
| Quality of life |  | at 3 months from treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thoracoscopy, Atrial fibrillation, Permanent Atrial fibrillation, catheter ablation, Arrhythmia, Heart