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Completed

NCT Number: NCT04067427

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

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.

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Meditation Pathologic Processes Pathological Conditions, Signs and Symptoms Persistent Atrial Fibrillation

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leipzig Heart Institute

Leipzig, Saxony, 04289, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mental training

Other

App-based mental training

Primary outcomes

  1. 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

  1. Atrial Fibrillation Effect on QualiTy of Life (AFEQT) score

    Time frame: Follow up (3 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

  2. Patient-Reported Outcome Measurement Information System (PROMIS) Global Health 10 score

    Time frame: 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.

  3. Atrial fibrillation burden

    Time frame: Follow up (3 months)

    Time in AF as assessed in 7-day-Holter

  4. Heart Rate

    Time frame: Follow up (3 months)

    Heart Rate during blood pressure measurement

  5. Blood pressure

    Time frame: Follow up (3 months)

    Office blood pressure measurement of diastolic and systolic blood pressure

  6. Atrial Fibrillation Effect on QualiTy of Life (AFEQT) score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Helios Health Institute GmbH

Other

Collaborators

  • Heart Center Leipzig - University Hospital

Registry information

Official study 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)

Acronym: Mental-AF

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 26, 2019
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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