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

Not Applicable

Completed

• Conditions: Paroxysmal Atrial Fibrillation; Meditation; Persistent Atrial Fibrillation
• Interventions: Other: Mental training

• Registration Number: NCT04067427
• Lead Sponsor: Helios Health Institute GmbH

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.

Study Timeline

• Study First Submitted: 2019-08-15
• Study Start: 2019-08-16
• Study First Submitted QC: 2019-08-22
• Study First Posted: 2019-08-26
• Primary Completion: 2022-01-15
• Study Completion: 2022-12-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mental training	Mental training	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.

Primary Outcome Measures

Name	Time	Method
Atrial Fibrillation (AF) 6 questionnaire score	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 Outcome Measures

Name	Time	Method
Atrial fibrillation burden	Follow up (3 months)	Time in AF as assessed in 7-day-Holter
Atrial Fibrillation Effect on QualiTy of Life (AFEQT) score	Follow up at 12 months	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
Blood pressure	Follow up (3 months)	Office blood pressure measurement of diastolic and systolic blood pressure
Patient-Reported Outcome Measurement Information System (PROMIS) Global Health 10 score	Follow up (3 months)	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.
Heart Rate	Follow up (3 months)	Heart Rate during blood pressure measurement

Trial Locations

Locations (1)

Leipzig Heart Institute; 🇩🇪 Leipzig, Saxony, Germany