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NCT Number: NCT05557526

Optimizing Quality of Life by Improved Patient Expectation Following Atrial Fibrillation Catheter Ablation

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evangelic Hospital Düsseldorf, Düsseldorf, North Rhine-Westfalia, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Expectation optimization

Other

A short (2-5 min) verbal intervention will be createad individually based on the expectation of the patient towards the procedure.

Primary outcomes

  1. 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

  1. Recurrence of atrial arrhythmias

    Time frame: 3 months

    Electrocardiographic documentation of any atrial arrhythmia with a duration >30 sec

  2. Recurrence of atrial arrhythmias

    Time frame: 12 months

    Electrocardiographic documentation of any atrial arrhythmia with a duration >30 sec

  3. Autonomic function (heart rate variability measurement)

    Time frame: 3 months

    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)

  4. Atrial volume [ml/m2]

    Time frame: 3 months

    Atrial volume measured via echocardiography will be compared between groups and time points (before versus 3 months after ablation)

  5. Left ventricular ejection fraction [%]

    Time frame: 3 months

    Left ventricular ejection fraction measured via echocardiography will be compared between groups and between time points (before versus 3 months after ablation)

  6. Inflammatory markers from blood samples

    Time frame: 3 months

    Inflammatory markers (including IFN-gamma, TNF-alpha TGF-beta, IL-1beta, IL-4, IL-6, IL-8, IL-10, IL-1, CRP, MPO, NGF, S100B, ANP, FABP4) in blood samples measured via enzyme-linked immunosorbent assays will be compared between groups and between time points (before versus 3 months after ablation)

  7. Treatment expectations (questionaire)

    Time frame: 3 months, 12 months

    Treatment expectations will be measured using the GEEE (Generic rating scale for previous treatment experiences, treatment expectations, and treatment effects) questionaire by Rief et al. and compared between groups and between time points (before versus 3 months after ablation / before versus 12 months after ablation). The subscale Generic rating scale for treatment expectations consists of three items that assess expectations towards treatment on a numeric rating scale with eleven response options (0-10); total scores of all three subscales combined range from 0-30 with higher scores indicating higher treatment expectations.

  8. Physical Activity (questionaire)

    Time frame: 3 months, 12 months

    Physical activity will be measured will be compared between groups and time points (before versus 3 months after ablation) using the short version of the International Physical Activity Questionnaire (IPAQ - short). The short version of the IPAQ is a 7-item questionnaire that assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives. Open-ended questions surrounding individuals' last 7-day recall of physical activity are considered to estimate total physical activity min/week and time spent sitting.

    Interpretation: Three levels (categories) of physical activity are proposed: low, moderate and high.

  9. General quality of life (questionaire)

    Time frame: 3 months, 12 months

    General quality of life of life will be compared between groups and between different time points (before versus 3 months after ablation) with "F-36 questionaire. SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

  10. Hospital Anxiety and Depression Scale HADS (questionaire)

    Time frame: 3 months, 12 months

    Hospital anxiety and depression will becompared between groups and time points (before versus 3 months after ablation) using the Hospital Anxiety and Depression Scale (HADS). It consists of 14 items rated zero to three on Likert scales, allowing computation of sub-scores for depression and anxiety symptoms. Subscores as well as total sum score will be applied.

  11. Cardiac Anxiety Questionnaire CAQ (questionaire)

    Time frame: 3 months, 12 months

    Cardiac anxiety will becompared between groups and time points (before versus 3 months after ablation) using the established Cardiac Anxiety Questionnaire CAQ to determine cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 68 for the German version, with a greater score indicating elevated cardiac anxiety.

Sponsors and collaborators

Lead sponsor

Evangelical Hospital Düsseldorf

Other

Collaborators

  • University Hospital, Essen

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Sep 28, 2022
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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