NCT06359132

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Start

First participant enrolled

January 1, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

April 11, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

January 9, 2024

Last Update Submit

April 8, 2024

Conditions

Atrial FibrillationArrhythmiaMobile HealthElectrical Cardioversion

Keywords

Atrial fibrillationArrhythmiaMobile healthElectrical cardioversion

Outcome Measures

Primary Outcomes (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

    through study completion, an average of 8 weeks

Secondary Outcomes (7)

  • 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

    through study completion, an average of 8 weeks

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

    through study completion, an average of 8 weeks

  • 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

    through study completion, an average of 8 weeks

  • Number of patients with paroxysmal AF

    through study completion, an average of 8 weeks

  • Time to recurrence of AF

    up to 4 weeks after ECV

  • +2 more secondary outcomes

Study Arms (1)

TeleConvert-AF

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 2025.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

RECRUITING

Viecuri Medical Center

Venlo, Limburg, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41624561DERIVED

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Dominik Linz, dr.

CONTACT

043-3877098dominik.linz@mumc.nl

Astrid Hermans, MSc

CONTACT

043-3871613astrid.hermans@mumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2024

First Posted

April 11, 2024

Study Start

January 1, 2022

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

April 11, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)