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Atrial FibrillationTeleConvert-AFNCT06359132

mHealth Rhythm Management in Terms of Cancelling Unnecessary Scheduled ECVs in Presumed Persistent AFpatients.

An observational study of Atrial Fibrillation and Arrhythmia, run by Maastricht University Medical Center at 2 sites in Netherlands.

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

Despite a clear definition in the European Society of Cardiology (ESC) guidelines, the differentiation between paroxysmal (self-terminating) and persistent (nonself- terminating) atrial fibrillation (AF) remains challenging in clinical practice. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Arrhythmia, Mobile Health
How many people
270 participants
Where
2 sitesNetherlands
Study dates
1 Jul 2022to 1 Jun 2025
Phase
Observational
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 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients with presumed persistent AF, age ≥18 years, scheduled for ECV, and in possession of a smartphone will be included in this study from January 2022 to January 2024.

Who may be able to join

  • Presumed persistent AF
  • Scheduled for ECV
  • Age ≥18 years
  • Smartphone possession
  • Ability and willing to sign informed consent
  • Ability and willing to use mobile phone app (FibriCheck)

Who cannot join

  • Deemed unsuitable for participation by attending physician
  • Presence of an active implanted electronic cardiac device

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites
  • Maastricht University Medical Center

    Maastricht, Limburg

  • Viecuri Medical Center

    Venlo, Limburg

Other trials in Netherlands

About this study

Official title: The Effect of Integrated Mobile Health-supported Heart Rhythm Management Around Electrical Cardioversion in Terms of Cancelling Unnecessary Scheduled ECV Appointments in Patients With Presumed Persistent Atrial Fibrillation (TeleConvert-AF)

Despite a clear definition in the European Society of Cardiology (ESC) guidelines, the differentiation between paroxysmal (self-terminating) and persistent (nonself- terminating) atrial fibrillation (AF) remains challenging in clinical practice. Some patients with presumed persistent AF are planned for electrical cardioversion (ECV) but appear to have a paroxysmal pattern or present in sinus rhythm (SR) at the scheduled ECV appointment. This results in unnecessary visits or interventions for patients, and costs and burden for the hospitals and health insurances. Based on the feasibility of the TeleCheck-AF approach, which is an on-demand mobile health (mHealth) infrastructure incorporating app-based heart rate and rhythm monitoring to support remote AF management through teleconsultation, the investigators aim to extend this mHealth approach to the management of presumed persistent AF patients planned for ECV.

Read the detailed description

When putted on the waiting list for ECV (at baseline), the case-coordinator (investigator or nurse) will contact the patient and provide an mHealthprescription, manual and app-activation QR-code to use the CE-marked mobile phone app using photoplethysmography (PPG) technology through the built-in mobile phone's camera to monitor rate and rhythm. After 24-hours the case-coordinator will check whether the patient activated the app, otherwise will contact patient for further support.

Recordings from the device will be sent to a secure cloud application. This cloud application is equipped with an automatic analyses algorithm with a red-amber-green alert system. Patients will be asked to use the app 3-times a day and in case of symptom onset and disappearance while being on the waiting list for ECV. In case of amber alert (recording in asystole > 5 sec, tachycardia > 170 bpm, bradycardia 110 bpm) the subject's care team will be notified of the alert by the investigators within one workday. The subject will then be contacted by the care team to intensify rate control if necessary. Subjects also have the possibility to contact the investigators directly if needed. In case of green alert (SR recording), the investigators will process the alert within one workweek. The subject will then be contacted by the investigators to visit the hospital and execute a 12-lead ECG to confirm SR as soon as possible. When SR is confirmed by ECG, scheduled ECV will be cancelled by the treating physician and rate/rhythm control medication might be intensified, this is part of standard care. When SR is not confirmed by ECG, treatment decisions will remain to the treating physician and he/she will decide whether or not to cancel scheduled ECV (based on PPG recordings). In the 4-weeks following scheduled ECV appointment, all patients will receive remote semi-continuous app-based rate/rhythm monitoring including red-amber- green alert notifications and will be asked to use the app 3-times a day and in case of symptom onset and disappearance. In case of an amber alert, the subject's care team will be notified of the alert by the investigators within one workday. The subject will then be contacted by the care team to intensify rate control if necessary. Subjects also have the possibility to contact the investigators directly if needed. Of importance is that alerts will only be assessed by the investigators during office hours. Patients will specifically (both verbally and written) be informed that in case of alarming symptoms during or outside of office hours, emergency services or their own general practitioner should be contacted. In all cases of acute emergencies, a patient should contact the emergency services. Furthermore, patients will be asked to fulfill a self-composed questionnaire based on the System Usability Scale extended with additional questions to assess the usability and user-friendliness of the refined TeleCheck-AF approach around ECV at 4-week follow-up. Also a self-composed questionnaire based on the HADS-A scale will be used to assess anxiety while using the mHealth-based refined TeleCheck-AF approach around ECV at four weeks.

Keywords
Atrial fibrillation, Arrhythmia, Mobile health, Electrical cardioversion
Medical subject headings
Atrial Fibrillation, Arrhythmias, Cardiac

What participants receive

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

Study groups in NCT06359132
Study groupRoleWhat they receive
TeleConvert-AFPatients with presumed persistent AF, age ≥18 years, scheduled for ECV, and in possession of a smartphone will be included in this study from January 2022 to January 2025.

What is being measured

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

  1. The number of cancelled unnecessary scheduled ECV appointments in patients with presumed persistent AF scheduled for ECV unnecessary scheduled ECV appointments

    The number of cancelled unnecessary scheduled ECV appointments in patients with presumed persistent AF scheduled for ECV

    Measured: through study completion, an average of 8 weeks

Secondary outcomes (7)
  1. Number of patients that agreed the refined TeleCheck-AF approach is usable and userfriendly as assessed by the System Usability Scale questionnaire extended with additional questions

    Number of patients that agreed the refined TeleCheck-AF approach is usable and userfriendly as assessed by the System Usability Scale questionnaire extended with additional questions

    Measured: through study completion, an average of 8 weeks

  2. Number of patients that agreed the refined TeleCheck-AF approach is anxious as assessed by the HADS-A scale questionnaire

    Number of patients that agreed the refined TeleCheck-AF approach is anxious as assessed by the HADS-A scale questionnaire

    Measured: through study completion, an average of 8 weeks

  3. Amount of saved costs for the hospitals and health insurances by using the TeleCheck-AF approach preceding ECV in terms of cancelling unnecessary scheduled ECV appointments

    Amount of saved costs for the hospitals and health insurances by using the TeleCheck-AF approach preceding ECV in terms of cancelling unnecessary scheduled ECV appointments

    Measured: through study completion, an average of 8 weeks

  4. Number of patients with paroxysmal AF

    Number of patients with paroxysmal AF assessed by the refined by the on-demand heart rate and rhythm monitoring application

    Measured: through study completion, an average of 8 weeks

  5. Time to recurrence of AF

    Time to recurrence of AF

    Measured: up to 4 weeks after ECV

  6. Time period of monitoring heart rate and rhythm using the mHealth-based application

    Time period of monitoring heart rate and rhythm using the mHealth-based application

    Measured: through study completion, an average of 8 weeks

  7. Amount of burden for the hospitals and health insurances by using the TeleCheck-AF approach preceding ECV in terms of cancelling unnecessary scheduled ECV appointments

    Amount of burden for the hospitals and health insurances by using the TeleCheck-AF approach preceding ECV in terms of cancelling unnecessary scheduled ECV appointments

    Measured: through study completion, an average of 8 weeks

Timeline

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

  1. First posted11 Apr 2024
  2. Study start1 Jul 2022
  3. Primary completion1 Jun 2025
  4. Study completion1 Jun 2025

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06359132
Sponsor's protocol ID
TeleConvert-AF
Acronym
TeleConvert-AF
Status last verified
Oct 2026
First submitted
9 Jan 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Engels MDEA, Hermans ANL, Hermans BJM, Luermans J, Chaldoupi SM, Hendriks JML, Lankveld T, Kessels MVM, Vorstermans BJGH, Beukema RJ, Vernooy K, Heesen W, Linz DK. Smartphone application-based heart rhythm monitoring to cancel scheduled electrical cardioversion in patients with spontaneous conversion of presumed persistent atrial fibrillation: TeleConvert-AF. Eur Heart J Digit Health. 2025 Dec 9;7(2):ztaf140. doi: 10.1093/ehjdh/ztaf140. eCollection 2026 Mar.

    PubMed 41624561

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation and Arrhythmia, run by Maastricht University Medical Center at 2 sites in Netherlands.

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 6 inclusion and 2 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. 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?

The number of cancelled unnecessary scheduled ECV appointments in patients with presumed persistent AF scheduled for ECV unnecessary scheduled ECV appointments (time frame: through study completion, an average of 8 weeks). 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 NCT06359132, 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 13 Oct 2026.

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