Back to resultsReducing Recurrence of Symptomatic Atrial Fibrillation After Catheter Ablation by App-based Mental Training (Mental-AF)
Primary Purpose
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Meditation
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mental training
Sponsored by
About this trial
This is an interventional prevention trial for Paroxysmal Atrial Fibrillation
Eligibility 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
Sites / Locations
- Leipzig Heart Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Mental training
Control
Arm Description
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.
AF ablation without subsequent mental training. AF 6 questionnaire will be answered weekly via the Mental-AF webpage.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
Atrial fibrillation burden
Time in AF as assessed in 7-day-Holter
Heart Rate
Heart Rate during blood pressure measurement
Blood pressure
Office blood pressure measurement of diastolic and systolic blood pressure
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
Full Information
NCT ID
NCT04067427
First Posted
August 15, 2019
Last Updated
March 13, 2023
Sponsor
Helios Health Institute GmbH
Collaborators
Heart Center Leipzig - University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04067427
Brief Title
Reducing Recurrence of Symptomatic Atrial Fibrillation After Catheter Ablation by App-based Mental Training
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 16, 2019 (Actual)
Primary Completion Date
January 15, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helios Health Institute GmbH
Collaborators
Heart Center Leipzig - University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Meditation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
183 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mental training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
AF ablation without subsequent mental training. AF 6 questionnaire will be answered weekly via the Mental-AF webpage.
Intervention Type
Other
Intervention Name(s)
Mental training
Intervention Description
App-based mental training
Primary Outcome Measure Information:
Title
Atrial Fibrillation (AF) 6 questionnaire score
Description
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.
Time Frame
12 weeks, assessed weekly
Secondary Outcome Measure Information:
Title
Atrial Fibrillation Effect on QualiTy of Life (AFEQT) score
Description
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
Time Frame
Follow up (3 months)
Title
Patient-Reported Outcome Measurement Information System (PROMIS) Global Health 10 score
Description
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.
Time Frame
Follow up (3 months)
Title
Atrial fibrillation burden
Description
Time in AF as assessed in 7-day-Holter
Time Frame
Follow up (3 months)
Title
Heart Rate
Description
Heart Rate during blood pressure measurement
Time Frame
Follow up (3 months)
Title
Blood pressure
Description
Office blood pressure measurement of diastolic and systolic blood pressure
Time Frame
Follow up (3 months)
Title
Atrial Fibrillation Effect on QualiTy of Life (AFEQT) score
Description
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
Time Frame
Follow up at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia A Lurz
Organizational Affiliation
Herzzentrum Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leipzig Heart Institute
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04289
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Reducing Recurrence of Symptomatic Atrial Fibrillation After Catheter Ablation by App-based Mental Training
We'll reach out to this number within 24 hrs