Clinical trial NCT05557526: Optimizing Quality of Life by Improved Patient Expectation Following Atrial Fibrillation Catheter Ablation
Official title: Optimizing Quality of Life by Improved Patient Expectation Following Atrial Fibrillation Catheter Ablation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Evangelical Hospital Düsseldorf
Sponsor class: OTHER
Collaborators: name: University Hospital, Essen
First posted: 2022-09-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility criteria: 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

Primary outcomes:
measure: Quality of life (questionaire)
timeFrame: 3 months
Secondary outcomes:
measure: Recurrence of atrial arrhythmias
timeFrame: 3 months
measure: Recurrence of atrial arrhythmias
timeFrame: 12 months
measure: Autonomic function (heart rate variability measurement)
timeFrame: 3 months
measure: Atrial volume [ml/m2]
timeFrame: 3 months
measure: Left ventricular ejection fraction [%]
timeFrame: 3 months
measure: Inflammatory markers from blood samples
timeFrame: 3 months
measure: Treatment expectations (questionaire)
timeFrame: 3 months, 12 months
measure: Physical Activity (questionaire)
timeFrame: 3 months, 12 months
measure: General quality of life (questionaire)
timeFrame: 3 months, 12 months
measure: Hospital Anxiety and Depression Scale HADS (questionaire)
timeFrame: 3 months, 12 months
measure: Cardiac Anxiety Questionnaire CAQ (questionaire)
timeFrame: 3 months, 12 months
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Evangelic Hospital Düsseldorf
state: North Rhine-Westfalia
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.