Detection of Asymptomatic Atrial Fibrillation in Persons of 65 Year of Age or Older
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT04375241
- Lead Sponsor
- Diagram B.V.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2168
- Age ≥65 years
- Is willing to give informed consent
- Known medical history with Atrial Fibrillation
- Not mental competent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Specificity of the mobile ECG device At screening Sensitivity of the mobile ECG device At screening
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Isala
🇳🇱Zwolle, Overijssel, Netherlands
Isala🇳🇱Zwolle, Overijssel, Netherlands