Atrial Fibrillation Clinical Trial
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.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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