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

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)

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.

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation; Meditation
• Intervention / Treatment: Other: Mental training

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 Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04289
      • Leipzig Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Mental training; App-based mental training
No Intervention: Control; AF ablation without subsequent mental training. AF 6 questionnaire will be answered weekly via the Mental-AF webpage.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Leipzig Heart Institute GmbH
• Collaborators: Heart Center Leipzig - University Hospital
• Investigators: Principal Investigator: Julia A Lurz, Herzzentrum Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2019
• Primary Completion (Actual): January 15, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: August 15, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: MAF2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No