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Paroxysmal Atrial FibrillationMental-AFNCT04067427

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

A study testing Mental training in people with Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Helios Health Institute GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 88 years
What is being tested?
Mental training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
183 participants
Where
1 siteGermany
Study dates
16 Aug 2019to 30 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 88 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Patients < 18 years of age
  • Unavailability of smart phone running at least Android 5 or iOS 9
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Leipzig Heart Institute

    Leipzig, Saxony, 04289

Other trials in Germany

About this study

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)

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.

Read the 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.

Being tested
Mental training
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mental trainingOther

    App-based mental training

Study groups in NCT04067427
Study groupRoleWhat they receive
Mental trainingActive comparatorAF 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.
Receives: Other: Mental training
ControlNo interventionAF ablation without subsequent mental training. AF 6 questionnaire will be answered weekly via the Mental-AF webpage.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks, assessed weekly

Secondary outcomes (6)

  1. 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

    Measured: Follow up (3 months)

  2. 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.

    Measured: Follow up (3 months)

  3. Atrial fibrillation burden

    Time in AF as assessed in 7-day-Holter

    Measured: Follow up (3 months)

  4. Heart Rate

    Heart Rate during blood pressure measurement

    Measured: Follow up (3 months)

  5. Blood pressure

    Office blood pressure measurement of diastolic and systolic blood pressure

    Measured: Follow up (3 months)

  6. 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

    Measured: Follow up at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2019
  2. Study start16 Aug 2019
  3. Primary completion15 Jan 2022
  4. Study completion30 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
183 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04067427
Sponsor's protocol ID
MAF2019
Acronym
Mental-AF
Status last verified
Mar 2023
First submitted
15 Aug 2019
Last updated
14 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lurz J, Hengelhaupt L, Unterhuber M, Stenzel L, Hilbert S, Schober AR, Dinov B, Darma A, Dagres N, Hindricks G, Lurz P, Bollmann A. App-Based Mental Training to Reduce Atrial Fibrillation-Related Symptoms After Pulmonary Vein Isolation: MENTAL AF Trial. J Am Heart Assoc. 2024 Jun 4;13(11):e033500. doi: 10.1161/JAHA.123.033500. Epub 2024 May 23.

    PubMed 38780185

Questions about this trial

What is this clinical trial studying?

A study testing Mental training in people with Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Helios Health Institute GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Atrial Fibrillation (AF) 6 questionnaire score (time frame: 12 weeks, assessed weekly). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04067427, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.

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