Reducing Recurrence of Symptomatic Atrial Fibrillation After Catheter Ablation by App-based Mental Training

Study Overview
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Brief Summary
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Atrial fibrillation (AF) is one of the most common heart rhythm disorders and it is associated with a variety of symptoms leading to a considerable deterioration in quality of life. The Mental-AF trial is intended to inquire if an app-based mental training can reduce the occurrence of symptomatic AF episodes within the blanking period, i.e. the first three months after catheter ablation for AF.

Detailed Description
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To explore the potential of a daily app-based mindfulness mental training in improving AF symptoms, assessed by self-reported outcome measures, i.e. the AF 6 questionnaire, AF Effect on QualiTy of Life (AFEQT) and Patient Reported Outcome Measurement Information System (PROMIS) Global Health questionnaires, as well as in reducing AF burden in 7-day-Holter, within the first 12 weeks following AF ablation.

Official Title
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To Reduce Recurrence of Symptomatic Atrial Fibrillation and Improve Quality of Life After Catheter Ablation for Atrial Fibrillation by App-based Mental Training (Mental AF)

Conditions
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Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Meditation

Intervention / Treatment
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* Other: Mental training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing AF ablation with symptomatic paroxysmal or chronic atrial fibrillation (EHRA II-IV) Availability of smart phone with the capability to run android 5 or iOS 9 or newer versions Capability to use mobile phone applications Internet access Consent to study participation Exclusion Criteria: Patients < 18 years of age Unavailability of smart phone running at least Android 5 or iOS 9 Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 88 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mental training<br>AF ablation followed by 3 months of a daily app-based mental training for 10 to 15 minutes per session. AF 6 questionnaire will be answered weekly via the Mental-AF webpage. | Other: Mental training<br>* App-based mental training<br>|
| No Intervention: Control<br>AF ablation without subsequent mental training. AF 6 questionnaire will be answered weekly via the Mental-AF webpage. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial Fibrillation (AF) 6 questionnaire score | Atrial fibrillation specific symptomatic outcome defined by AF 6 sum scores during the first 12 weeks following AF ablation, based on a 10-point Likert scale, ranging from 0 (no symptoms) to 10 (severe symptoms), sum scores ranging from 0 to 60. | 12 weeks, assessed weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial Fibrillation Effect on QualiTy of Life (AFEQT) score | Effects of AF on quality of Life, assessed by a 20-item questionnaire with 4 conceptual domains (daily Activities, treatment concern, symptoms and treatment satisfaction) on a 7-point Likert scale, responses ranging from 1 (no symptoms/limitations) to 7 (most severe limitations/symptoms), higher scores indicating better health status, the raw scores can be transformed to a 0 to 100 scale adjusting for missing data | Follow up (3 months) | 
| Patient-Reported Outcome Measurement Information System (PROMIS) Global Health 10 score | PROMIS Global Health questionnaire for the assessment of physical and mental health domains by 10 items using a 5-point Likert scale, ranging from (5) excellent to (1) poor. Higher scores indicate a healthier patient. | Follow up (3 months) | 
| Atrial fibrillation burden | Time in AF as assessed in 7-day-Holter | Follow up (3 months) | 
| Heart Rate | Heart Rate during blood pressure measurement | Follow up (3 months) | 
| Blood pressure | Office blood pressure measurement of diastolic and systolic blood pressure | Follow up (3 months) | 
| Atrial Fibrillation Effect on QualiTy of Life (AFEQT) score | Effects of AF on quality of Life, assessed by a 20-item questionnaire with 4 conceptual domains (daily Activities, treatment concern, symptoms and treatment satisfaction) on a 7-point Likert scale, responses ranging from 1 (no symptoms/limitations) to 7 (most severe limitations/symptoms), higher scores indicating better health status, the raw scores can be transformed to a 0 to 100 scale adjusting for missing data | Follow up at 12 months |