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

Atrial Fibrillation Clinical Trial

— DETECT AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04375241
• Other study ID #: 9275
• Status: Completed
• Start date: July 2, 2018
• Est. completion date: April 30, 2021

Study information

• Verified date: July 2022
• Source: Diagram B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Study design:

Prospective validation study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2168
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age =65 years

• Is willing to give informed consent

Exclusion Criteria:

• Known medical history with Atrial Fibrillation

• Not mental competent

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Netherlands	Isala	Zwolle	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Diagram B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the mobile ECG device		At screening
Primary	Specificity of the mobile ECG device		At screening