Optimizing Quality of Life by Improved Patient Expectation Following Atrial Fibrillation Catheter Ablation
Overview
- Phase
- Not Applicable
- Intervention
- Standard Medical Care Control Group
- Conditions
- Atrial Fibrillation
- Sponsor
- Evangelical Hospital Düsseldorf
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Quality of life (questionaire)
- Status
- Recruiting
- Last Updated
- 4 days ago
Overview
Brief Summary
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).
Investigators
Christian Meyer
Head of the Division of Cardiology, Angiology and Intensive Care
Evangelical Hospital Düsseldorf
Eligibility Criteria
Inclusion Criteria
- •symptomatic atrial fibrillation
- •indication for pulmonary vein isolation
- •sufficient command of the German language
Exclusion Criteria
- •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
- •atrial fibrillation induced by intoxication, medicamentation or infection
- •inability to grap the course of the study
Arms & Interventions
Standard Medical Care Control Group
Patients with atrial fibrillation receiving catheter ablation of atrial fibrillation without additional intervention.
Optimize Expectation Group
Patients with atrial fibrillation receiving catheter ablation of atrial fibrillation and an additional verbal intervention to optimize the expectation of the patient towards the procedure.
Intervention: Expectation optimization
Outcomes
Primary Outcomes
Quality of life (questionaire)
Time Frame: 3 months
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
- Left ventricular ejection fraction [%](3 months)
- Physical Activity (questionaire)(3 months, 12 months)
- Autonomic function (heart rate variability measurement)(3 months)
- Inflammatory markers from blood samples(3 months)
- Treatment expectations (questionaire)(3 months, 12 months)
- General quality of life (questionaire)(3 months, 12 months)
- Hospital Anxiety and Depression Scale HADS (questionaire)(3 months, 12 months)
- Recurrence of atrial arrhythmias(12 months)
- Atrial volume [ml/m2](3 months)
- Cardiac Anxiety Questionnaire CAQ (questionaire)(3 months, 12 months)
- Recurrence of atrial arrhythmias(3 months)