NCT04375241

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,168 (actual)
• Sponsor: Diagram B.V. · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Study design: Prospective validation study.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-07-02
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2020-05-05
• Last updated: 2022-07-12

Locations

1 site across 1 country: Netherlands