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

Paroxysmal Atrial Fibrillation Clinical Trial

— Mental-AF  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04067427
• Other study ID #: MAF2019
• Status: Completed
• Phase: N/A
• Start date: August 16, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2023
• Source: Leipzig Heart Institute GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: December 30, 2022
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Meditation
• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation
• Recurrence

Intervention

Other:
• Mental training
App-based mental training

Locations

Country	Name	City	State
Germany	Leipzig Heart Institute	Leipzig	Saxony

Sponsors (2)

Lead Sponsor	Collaborator
Leipzig Heart Institute GmbH	Heart Center Leipzig - University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Atrial fibrillation burden	Time in AF as assessed in 7-day-Holter	Follow up (3 months)
Secondary	Heart Rate	Heart Rate during blood pressure measurement	Follow up (3 months)
Secondary	Blood pressure	Office blood pressure measurement of diastolic and systolic blood pressure	Follow up (3 months)
Secondary	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