Detection of Asymptomatic Atrial Fibrillation in Persons of 65 Year of Age or Older
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Diagram B.V.
- Enrollment
- 2168
- Locations
- 1
- Primary Endpoint
- Specificity of the mobile ECG device
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Detailed Description
Study design: Prospective validation study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥65 years
- •Is willing to give informed consent
Exclusion Criteria
- •Known medical history with Atrial Fibrillation
- •Not mental competent
Outcomes
Primary Outcomes
Specificity of the mobile ECG device
Time Frame: At screening
Sensitivity of the mobile ECG device
Time Frame: At screening