Optimizing Quality of Life by Improved Patient Expectation Following Atrial Fibrillation Catheter Ablation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Quality of life (questionaire)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic atrial fibrillation
- •indication for pulmonary vein isolation
- •sufficient command of the German language
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Expectation optimization (Other)
结局指标
主要结局
Quality of life (questionaire)
时间窗: 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.
次要结局
- 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)
研究者
Christian Meyer
Head of the Division of Cardiology, Angiology and Intensive Care
Evangelical Hospital Düsseldorf