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Atrial FibrillationNCT05557526

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

A study testing Expectation optimization in people with Atrial Fibrillation, run by Evangelical Hospital Düsseldorf at 2 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Expectation optimization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesGermany
Study dates
9 Jun 2022to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • symptomatic atrial fibrillation
  • indication for pulmonary vein isolation
  • sufficient command of the German language

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Germany2 sites, 2 recruiting

  • Evangelic Hospital Düsseldorf

    Düsseldorf, North Rhine-Westfalia, 40217

    Christian Meyer, MD, 00492119191855, christian.meyer@evk-duesseldorf.de

    Katharina Scherschel, PhD, katharina.scherschel@evk-duesseldorf.de

    Recruiting

  • Westdeutsches Herz- und Gefäßzentrum

    Essen

    Jungen Christiane, MD, 0049201280220, Christiane.Jungen@uk-essen.de

    Recruiting

Other trials in Germany

About this study

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).

Being tested
Expectation optimization
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Expectation optimizationOther

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

Study groups in NCT05557526
Study groupRoleWhat they receive
Standard Medical Care Control GroupNo interventionPatients with atrial fibrillation receiving catheter ablation of atrial fibrillation without additional intervention.
Optimize Expectation GroupExperimentalPatients with atrial fibrillation receiving catheter ablation of atrial fibrillation and an additional verbal intervention to optimize the expectation of the patient towards the procedure.
Receives: Other: Expectation optimization

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

Secondary outcomes (11)

  1. Recurrence of atrial arrhythmias

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

    Measured: 3 months

  2. Recurrence of atrial arrhythmias

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

    Measured: 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)

    Measured: 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)

    Measured: 3 months

  5. Left ventricular ejection fraction [%]

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

    Measured: 3 months

  6. Inflammatory markers from blood samples

    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)

    Measured: 3 months

  7. Treatment expectations (questionaire)

    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.

    Measured: 3 months, 12 months

  8. Physical Activity (questionaire)

    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.

    Measured: 3 months, 12 months

  9. General quality of life (questionaire)

    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.

    Measured: 3 months, 12 months

  10. Hospital Anxiety and Depression Scale HADS (questionaire)

    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.

    Measured: 3 months, 12 months

  11. Cardiac Anxiety Questionnaire CAQ (questionaire)

    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.

    Measured: 3 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2022
  2. Study start9 Jun 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05557526
Sponsor's protocol ID
IMPROVE AF
Status last verified
Apr 2026
First submitted
7 Jan 2022
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Salzmann S, Euteneuer F, Laferton JAC, Auer CJ, Shedden-Mora MC, Schedlowski M, Moosdorf R, Rief W. Effects of Preoperative Psychological Interventions on Catecholamine and Cortisol Levels After Surgery in Coronary Artery Bypass Graft Patients: The Randomized Controlled PSY-HEART Trial. Psychosom Med. 2017 Sep;79(7):806-814. doi: 10.1097/PSY.0000000000000483.

    PubMed 28846584

  • Rief W, Shedden-Mora MC, Laferton JA, Auer C, Petrie KJ, Salzmann S, Schedlowski M, Moosdorf R. Preoperative optimization of patient expectations improves long-term outcome in heart surgery patients: results of the randomized controlled PSY-HEART trial. BMC Med. 2017 Jan 10;15(1):4. doi: 10.1186/s12916-016-0767-3.

    PubMed 28069021

  • Schedlowski M, Enck P, Rief W, Bingel U. Neuro-Bio-Behavioral Mechanisms of Placebo and Nocebo Responses: Implications for Clinical Trials and Clinical Practice. Pharmacol Rev. 2015 Jul;67(3):697-730. doi: 10.1124/pr.114.009423.

    PubMed 26126649

  • Laferton JA, Auer CJ, Shedden-Mora MC, Moosdorf R, Rief W. Optimizing preoperative expectations in cardiac surgery patients is moderated by level of disability: the successful development of a brief psychological intervention. Psychol Health Med. 2016;21(3):272-85. doi: 10.1080/13548506.2015.1051063. Epub 2015 Jun 4.

    PubMed 26042657

  • Kuniss M, Pavlovic N, Velagic V, Hermida JS, Healey S, Arena G, Badenco N, Meyer C, Chen J, Iacopino S, Anselme F, Packer DL, Pitschner HF, Asmundis C, Willems S, Di Piazza F, Becker D, Chierchia GB; Cryo-FIRST Investigators. Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation. Europace. 2021 Jul 18;23(7):1033-1041. doi: 10.1093/europace/euab029.

    PubMed 33728429

Questions about this trial

What is this clinical trial studying?

A study testing Expectation optimization in people with Atrial Fibrillation, run by Evangelical Hospital Düsseldorf at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life (questionaire) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05557526, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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