MedPath

Detection of Asymptomatic Atrial Fibrillation in persons of 65 year of age or older

Conditions
Asymptomatic Atrial FibrillationAAFAFAsymptomatisch atriumfibrilleren
Registration Number
NL-OMON25405
Lead Sponsor
Diagram B.VDokter Stolteweg 968025 AZ ZwolleThe Netherlands
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
4000
Inclusion Criteria

 -Age ≥65 years

 -Is giving informed consent

Exclusion Criteria

-Known medical history with Atrial Fibrillation

 -Not mental competent

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary objective:<br /><br>The aim of this study is to determine the accuracy, sensitivity and specificity of the AliveCor Kardia automated AF algorithm in a transmural care setting in the Netherlands. In patients &#8805;65 years without symptoms associated with (A)AF.
Secondary Outcome Measures
NameTimeMethod
Secundary objectives:<br /><br>&#61623; Gain insight into AAF prevalence in the Netherlands<br /><br>&#61623; To determine sensitivity and specificity of the AliveCor Kardia system in combination with the added expert sECG analysis findings<br /><br>&#61623; To determine negative predictive value of the AliveCor Kardia system<br /><br>&#61623; Users and patient satisfaction about AliveCor Kardia system screening<br /><br>&#61623; Feasibility of screening of 4000 persons &#8804;2 year<br /><br>&#61623; Feasibility of structural implementation of the AliveCor Kardia system in community care (general practitioners and other care givers)
© Copyright 2025. All Rights Reserved by MedPath