About this trial
The aim is to investigate whether optimizing patients' expectations towards the interventional treatment of atrial fibrillation (catheter ablation) leads to a lower disease-related impairment of the patients compared to the control group in the first three months after ablation (the so-called blanking period).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
symptomatic atrial fibrillation
indication for pulmonary vein isolation
sufficient command of the German language
Disqualifiers
age <18 years
permanent atrial fibrillation
presence of psychiatric disorders which impair the study participitatin
presence of another medical condiction which influences quality of life stronger than the cardiac condition
Trial design
Parallel
Treatments tested in this trial
Expectation optimization
Other interventionA short (2-5 min) verbal intervention will be createad individually based on the expectation of the patient towards the procedure.
Treatment groups
Trial outcomes
Primary outcomes
Quality of life (questionaire)
Quality of life of life will be compared between groups and between different time points (before versus 3 months after ablation) with "the atrial fibrillation effect on quality-of-life (AFEQT) questionnaire". An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore, a positive change in score corresponds to improvement in AF symptoms.
Secondary outcomes
Recurrence of atrial arrhythmias
Electrocardiographic documentation of any atrial arrhythmia with a duration \>30 sec
Recurrence of atrial arrhythmias
Electrocardiographic documentation of any atrial arrhythmia with a duration \>30 sec
Autonomic function (heart rate variability measurement)
Autonomic function will be assessed by heart rate variability measurement (low frequency and high frequency domain, root mean square of successive differences) to compare patients between groups and time points (before versus 3 months after ablation)
Atrial volume [ml/m2]
Atrial volume measured via echocardiography will be compared between groups and time points (before versus 3 months after ablation)
Sponsors and contacts
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Evangelical Hospital Düsseldorf
Lead sponsor
University Hospital, Essen
Collaborator