Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Permanent Atrial fibrillation, catheter ablation, thoracoscopy, Arrhythmia, Heart
Brief summary
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
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
Interventions
PROCEDURECatheter ablation
PROCEDUREThoracoscopic epicardial ablation
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of sinus rhythm | after 6 months from treatment |
Secondary
| Measure | Time frame |
|---|---|
| cost-effectiveness | during 12 months from treatment |
| structural changes (evaluated by echocardiography) | during 12 months from treatment |
| p-BNP | during 12 months from treatment |
| complications | 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 |
| inflammatory markers | during 12 months from treatment |
Countries
Denmark
Outcome results
None listed