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| Name | Class |
|---|---|
| Heart Center Leipzig - University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mental training | Active Comparator | 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. |
|
| Control | No Intervention | AF ablation without subsequent mental training. AF 6 questionnaire will be answered weekly via the Mental-AF webpage. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mental training | Other | App-based mental training |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia A Lurz | Herzzentrum Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leipzig Heart Institute | Leipzig | Saxony | 04289 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38780185 | Derived | Lurz J, Hengelhaupt L, Unterhuber M, Stenzel L, Hilbert S, Schober AR, Dinov B, Darma A, Dagres N, Hindricks G, Lurz P, Bollmann A. App-Based Mental Training to Reduce Atrial Fibrillation-Related Symptoms After Pulmonary Vein Isolation: MENTAL AF Trial. J Am Heart Assoc. 2024 Jun 4;13(11):e033500. doi: 10.1161/JAHA.123.033500. Epub 2024 May 23. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |