NCT04375241

Brief Summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia. Although the condition itself is not life-threatening, the complications result in increased morbidity and mortality. AF is often asymptomatic and a considerable number of people suffering from AF are not aware of their condition. Unfortunately, a cerebral infarction is often the first clinical manifestation. The idea to screen subjects opportunistically for Asymptomatic Atrial Fibrillation (AAF) was infeasible until recently. However, with a recently-developed smartphone connected Mobile ECG Device (MED), this seems to be feasible after all. The main objectives are:

  • To examine the feasibility of screening subjects of ≥65 years old for AAF.
  • To validate the smartphone connected MED as an AAF screening instrument for application in transmural care in the Netherlands.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,168

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Typical duration for all trials

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

Study Start

First participant enrolled

July 2, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

July 12, 2022

Status Verified

July 1, 2022

Enrollment Period

2.8 years

First QC Date

May 1, 2020

Last Update Submit

July 8, 2022

Conditions

Atrial Fibrillation

Keywords

Mobile ECG deviceAsymptomatic atrial fibrillation

Outcome Measures

Primary Outcomes (2)

  • Sensitivity of the mobile ECG device

    At screening

  • Specificity of the mobile ECG device

    At screening

Study Arms (1)

Screening with Mobile ECG Device

Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device

Other: Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device

Interventions

Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG DeviceOTHER

Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device

Screening with Mobile ECG Device

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participants of this study will be subjects who visit their general practicioner or cardiologist or who visit the DETECT AF team at an event.

You may qualify if:

  • Age ≥65 years
  • Is willing to give informed consent

You may not qualify if:

  • Known medical history with Atrial Fibrillation
  • Not mental competent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isala

Zwolle, Overijssel, 8025AB, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2020

First Posted

May 5, 2020

Study Start

July 2, 2018

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

July 12, 2022

Record last verified: 2022-07

Locations

NL(1)