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

NCT05557526 | Recruiting

• 1 other identifier: IMPROVE AF
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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).

Conditions

Atrial Fibrillation

Outcome Measures

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.

  3 months

Secondary Outcomes (11)

• Recurrence of atrial arrhythmias

  3 months

• Recurrence of atrial arrhythmias

  12 months

• Autonomic function (heart rate variability measurement)

  3 months

• Atrial volume [ml/m2]

  3 months

• Left ventricular ejection fraction [%]

  3 months

Study Arms (2)

Standard Medical Care Control Group

NO INTERVENTION

Patients with atrial fibrillation receiving catheter ablation of atrial fibrillation without additional intervention.

Optimize Expectation Group

EXPERIMENTAL

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.

Other: Expectation optimization

Interventions

Expectation optimization OTHER

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

Optimize Expectation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Evangelical Hospital Düsseldorf: lead
• University Hospital, Essen: collaborator

Study Sites (2)

Evangelic Hospital Düsseldorf

Düsseldorf, North Rhine-Westfalia, 40217, Germany

RECRUITING

Westdeutsches Herz- und Gefäßzentrum

Essen, Germany

RECRUITING

Related Publications (5)

• 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.

  PMID: 28846584 BACKGROUND

• 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.

  PMID: 28069021 BACKGROUND

• 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.

  PMID: 26126649 BACKGROUND

• 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.

  PMID: 26042657 BACKGROUND

• 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.

  PMID: 33728429 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Division of Cardiology, Angiology and Intensive Care

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: September 28, 2022
• Study Start: June 9, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)