Menu
Recruiting NCT05557526

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

No phase Interventional Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Expectation optimization.
Who it may be relevant to
Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

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

Primary outcome measures

  • Quality of life (questionaire) [Time frame: 3 months]
Secondary outcome measures (11)
  • Recurrence of atrial arrhythmias [Time frame: 3 months]
  • Recurrence of atrial arrhythmias [Time frame: 12 months]
  • Autonomic function (heart rate variability measurement) [Time frame: 3 months]
  • Atrial volume [ml/m2] [Time frame: 3 months]
  • Left ventricular ejection fraction [%] [Time frame: 3 months]
  • Inflammatory markers from blood samples [Time frame: 3 months]
  • Treatment expectations (questionaire) [Time frame: 3 months, 12 months]
  • Physical Activity (questionaire) [Time frame: 3 months, 12 months]
  • General quality of life (questionaire) [Time frame: 3 months, 12 months]
  • Hospital Anxiety and Depression Scale HADS (questionaire) [Time frame: 3 months, 12 months]
  • Cardiac Anxiety Questionnaire CAQ (questionaire) [Time frame: 3 months, 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Germany · 2 centers
  • Evangelic Hospital Düsseldorf — Düsseldorf
  • Westdeutsches Herz- und Gefäßzentrum — Essen

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. PMID 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. PMID 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. PMID 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. PMID 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/europa PMID 33728429

Identifiers

NCT: NCT05557526 · IMPROVE AF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗