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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Paroxysmal Atrial Fibrillation
- Sponsor
- Helios Health Institute GmbH
- Enrollment
- 183
- Locations
- 1
- Primary Endpoint
- Atrial Fibrillation (AF) 6 questionnaire score
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Atrial Fibrillation (AF) 6 questionnaire score
Time Frame: 12 weeks, assessed weekly
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.
Secondary Outcomes
- Atrial fibrillation burden(Follow up (3 months))
- Atrial Fibrillation Effect on QualiTy of Life (AFEQT) score(Follow up at 12 months)
- Blood pressure(Follow up (3 months))
- Patient-Reported Outcome Measurement Information System (PROMIS) Global Health 10 score(Follow up (3 months))
- Heart Rate(Follow up (3 months))