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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067427
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : October 23, 2019
Sponsor:
Collaborator:
Heart Center Leipzig - University Hospital
Information provided by (Responsible Party):
Leipzig Heart 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.

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation Mediation Other: Mental training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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)
Actual Study Start Date : August 16, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067427


Contacts
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Contact: Julia A Lurz, MD +49341865252085 julia.lurz@medizin.uni-leipzig.de

Locations
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Germany
Leipzig Heart Institute Recruiting
Leipzig, Saxony, Germany, 04289
Contact: Julia A Lurz, MD    +49341865252085    julia.lurz@medizin.uni-leipzig.de   
Sponsors and Collaborators
Leipzig Heart Institute GmbH
Heart Center Leipzig - University Hospital
Investigators
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Principal Investigator: Julia A Lurz Herzzentrum Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany
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Responsible Party: Leipzig Heart Institute GmbH
ClinicalTrials.gov Identifier: NCT04067427    
Other Study ID Numbers: MAF2019
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes