NCT04067427

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

August 16, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

2.4 years

First QC Date

August 15, 2019

Last Update Submit

March 13, 2023

Conditions

Paroxysmal Atrial FibrillationPersistent Atrial FibrillationMeditation

Outcome Measures

Primary Outcomes (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.

    12 weeks, assessed weekly

Secondary Outcomes (6)

  • Atrial Fibrillation Effect on QualiTy of Life (AFEQT) score

    Follow up (3 months)

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

    Follow up (3 months)

  • Atrial fibrillation burden

    Follow up (3 months)

  • Heart Rate

    Follow up (3 months)

  • Blood pressure

    Follow up (3 months)

  • +1 more secondary outcomes

Study Arms (2)

Mental training

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

AF ablation without subsequent mental training. AF 6 questionnaire will be answered weekly via the Mental-AF webpage.

Interventions

Mental trainingOTHER

App-based mental training

Mental training

Eligibility Criteria

Age18 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leipzig Heart Institute

Leipzig, Saxony, 04289, Germany

Location

Related Publications (1)

  • 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.

    PMID: 38780185DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Julia A Lurz

    Herzzentrum Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2019

First Posted

August 26, 2019

Study Start

August 16, 2019

Primary Completion

January 15, 2022

Study Completion

December 30, 2022

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)