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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-16

Study Completion Date

2022-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Outcomes of Early Referral to Radiofrequency Ablation in Symptomatic Atrial Fibrillation Patients.

NCT05559073

Atrial Fibrillation Radiofrequency Ablation

UNKNOWN

Meditation and Education That is Nurse Delivered for Symptom Management in Paroxysmal Atrial Fibrillation (PAF)

NCT03834844

Paroxysmal Atrial Fibrillation

ACTIVE_NOT_RECRUITING NA

FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation

NCT06260670

Persistent Atrial Fibrillation Longstanding Persistent Atrial Fibrillation Atrial Fibrillation, Persistent +1 more

COMPLETED NA

Symptom Preoccupation in Atrial Fibrillation (AF) and Its Role in AF-related Disability

NCT04123327

Atrial Fibrillation

COMPLETED

Internet-based Cognitive Behavior Therapy for Atrial Fibrillation

NCT02694276

Atrial Fibrillation Arrhythmia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation Meditation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Mental training

Intervention Type OTHER

App-based mental training

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mental training

App-based mental training

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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