Detection of Asymptomatic Atrial Fibrillation in Persons of 65 Year of Age or Older (DETECT AF)

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device

Detailed Description

Study design:

Prospective validation study.

• Study Type: Observational
• Enrollment (Actual): 2168

Contacts and Locations

Study Locations

• Netherlands
  • Overijssel
    • Zwolle, Overijssel, Netherlands, 8025AB
      • Isala

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Known medical history with Atrial Fibrillation
• Not mental competent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity of the mobile ECG device	At screening
Specificity of the mobile ECG device	At screening

Collaborators and Investigators

• Sponsor: Diagram B.V.

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2018
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: May 1, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 8, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Mobile ECG device; Asymptomatic atrial fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 9275

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We have not yet decided to share the individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No