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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEvangelical Hospital Düsseldorf

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Expectation optimization

    Other intervention

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Standard Medical Care Control GroupNo intervention 0 interventions
Group B: Optimize Expectation GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months

Secondary outcomes

1

Recurrence of atrial arrhythmias

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

Time frame
3 months
2

Recurrence of atrial arrhythmias

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

Time frame
12 months
3

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)

Time frame
3 months
4

Atrial volume [ml/m2]

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

Time frame
3 months

Other outcomes

Sponsors and contacts

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Evangelical Hospital Düsseldorf

Lead sponsor

University Hospital, Essen

Collaborator