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OpenTrials
Completed

NCT Number: NCT04375241

Detection of Asymptomatic Atrial Fibrillation in Persons of 65 Year of Age or Older

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.

Completed

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Isala

Zwolle, Overijssel, 8025AB, Netherlands

About this study

Study design:

Prospective validation study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Known medical history with Atrial Fibrillation
  • Not mental competent

Treatment and study plan

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

Primary outcomes

  1. Sensitivity of the mobile ECG device

    Time frame: At screening

  2. Specificity of the mobile ECG device

    Time frame: At screening

Sponsors and collaborators

Lead sponsor

Diagram B.V.

Other

Registry information

Acronym: DETECT AF

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 5, 2020
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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