An interventional study of FibriCheck in Atrial Fibrillation Paroxysmal, sponsored by KU Leuven. Withdrawn. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-20.
Sponsored by KU Leuven · Not applicable, Interventional, and Screening
Atrial fibrillation is a cardiac arrhythmia commonly encountered in a primary care setting. Current screening is limited to pulse palpation and ECG confirmation when an irregular pulse is found. Paroxysmal atrial fibrillation will, however, still be difficult to pick up. With the advent of smartphones, screening could be more cost-efficient by making use of simple applications, lowering the need for intensive screening to discover (paroxysmal) atrial fibrillation.
This cluster randomized trial will examine the effect of using a smartphone-based application such as FibriCheck® on the detection rate of atrial fibrillation in a Flemish general practice population. This study will be conducted in 22 primary care practices across the Flanders region of Belgium and will last 12 months. Patients above 65 years of age will be divided in control and intervention groups on the practice level. The control group will be subjected to standard opportunistic screening only, while the intervention group will be prescribed the FibriCheck® app on top of this opportunistic screening. The difference in detection rate between control and intervention groups will be calculated at the end of the study.
The investigators will use the online platform INTEGO for pseudonymized data collection and analysis, and risk calculation.
Smartphone applications might offer a way to cost-effectively screen for (paroxysmal) atrial fibrillation in a primary care setting. This could open the door for the update of future screening guidelines.
3,870 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.
Browse Atrial Fibrillation studies →KU Leuven is the lead sponsor of 358 studies on the registry; 62 are open to participants now.
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Exclusion Criteria:
In every cluster designated as a control group, patients aged 65 or older will be selected according to the inclusion criteria. The difference here is that patients will be given the standard opportunistic screening instead: pulse palpation and a 12-lead ECG when an irregular rhythm is found. This is current best practice.
In every cluster designated as an intervention group, patients aged 65 or older will be selected according to the inclusion criteria. Within this group, high-risk patients will be identified using the CHARGE-AF score, and will be prescribed the FibriCheck® app.
Device: FibriCheck
FibriCheck is a smartphone application that measures hearth rhythm using the phone's built-in camera. It is able to detect aberrant rhythms, such as atrial fibrillation.
Detection rate of AF in patients 65 years and older
The detection rate of AF in both the control and intervention group will be calculated after 4 weeks. A significant difference in both groups will be noted. Compared with previous studies of similar design (32-34), we will realistically assume a 2-fold increase in the detection rate of AF in the intervention group to be significant.
Time frame: 4 weeks for each participant
Thromboembolic complications
We will track incidence of transient ischemic attack or ischemic stroke during the study period, in addition to the eventual difference between both study populations.
Time frame: 12 months
Death
We will keep track of all-cause mortality during the study period, as well as difference in mortality between control and intervention populations.
Time frame: 12 months
Compliance
We will keep track of patient compliance during the study period (e.g. minimum number of measurements with FibriCheck®).
Time frame: 12 months
No study locations are listed for this record.
Plan to share: Yes — Individual participant data will be available upon reasonable request. The trial's dataset will be held at the University of Leuven, Belgium, and can be shared upon contacting the principal investigator.
This study is withdrawn, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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