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| ID | Type | Description | Link |
|---|---|---|---|
| KF - 01-284215 |
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Patients with permanent AF are seldomly symptomatic enough to justify intervention. We decided to stop inclusion due to low recruitment rate.
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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.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter ablation | Procedure | |||
| Thoracoscopic epicardial ablation | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of sinus rhythm | after 6 months from treatment |
| Measure | Description | Time Frame |
|---|---|---|
| complications | during 12 months from treatment | |
| cost-effectiveness | during 12 months from treatment | |
| structural changes (evaluated by echocardiography) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesper H Svendsen, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Risghospitalet, | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| 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 |
| D013514 |
| Surgical Procedures, Operative |