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

NCT ID: NCT05557526

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-09

Study Completion Date

2024-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard Medical Care Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Optimize Expectation Group

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.

Group Type EXPERIMENTAL

Expectation optimization

Intervention Type OTHER

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

Interventions

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Expectation optimization

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Essen

OTHER

Sponsor Role collaborator

Evangelical Hospital Düsseldorf

OTHER

Sponsor Role lead

Responsible Party

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Christian Meyer

Head of the Division of Cardiology, Angiology and Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Evangelic Hospital Düsseldorf

Düsseldorf, North Rhine-Westfalia, Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Christian Meyer, MD

Role: primary

00492119191855

Katharina Scherschel, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 28846584 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28069021 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26126649 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26042657 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33728429 (View on PubMed)

Other Identifiers

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IMPROVE AF

Identifier Type: -

Identifier Source: org_study_id

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