Detection of Atrial Fibrillation in Different Patient Target Groups Using the FibriCheck Smartphone Application

Study Overview
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Brief Summary
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FibriCheck is a Conformité Européenne (CE)-approved (class IIa) medically diagnostic application that allows for heart rhythm registrations based on an optical signal captured via the smartphone camera. FibriCheck is only available on prescription causing the physician to stay in the 'driving seat' and the application distribution to be traced. By using FibriCheck, a medically validated smartphone application, daily rhythm measurements can be performed using only the smartphone of the patient. This allows for the heart rhythm to be registered and monitored in a home environment and the data to be automatically sent to the physician. This enables the implementation of FibriCheck in two types of scenarios: Scenario 1: the follow-up of patients with high risk parameters for AF development for primary and secondary prevention, whereby detection of AF will result in therapeutic intervention Scenario 2: the realisation of monitoring of the heart rhythm of patients post intervention in a home environment

Detailed Description
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Atrial fibrillation (AF) is the most common heart rhythm disorder affecting 50 million people in Europe and the U.S. It is associated with an increasing mortality and risk for transient cerebrovascular incidents and dementia. De novo AF is in most cases asymptomatic and paroxysmal, causing the diagnosis to be made either by chance or in response to an incident. This drastically impacts the quality of life of the patient and is accompanied with a high socio-economic cost. Guidelines indicate that anticoagulation in patients diagnosed with AF is a cost-effective solution for the prevention of strokes. In addition, depending on the target group, patients identified with AF can receive therapy in order to control the heart rhythm. These procedures (cardioversion and ablation) often result in follow-up consultations that can be avoided if the heart rhythm can be monitored remotely. By using FibriCheck, a medically validated smartphone application, daily rhythm measurements can be performed using only the smartphone of the patient. This allows for the heart rhythm to be registered and monitored in a home environment and the data to be automatically sent to the physician. This enables the implementation of FibriCheck in two types of scenarios: Scenario 1: the follow-up of patients with high risk parameters for AF development for primary and secondary prevention, whereby detection of AF will result in therapeutic intervention Scenario 2: the realisation of monitoring of the heart rhythm of patients post intervention in a home environment The follow-up of patients is still driven by the treating physician(s). The objective is to implement a correct and successful process management allowing a smooth implementation of an application on prescription. Short- and long-term benefits the project wants to prove: Short-term: - AF can successfully be detected in a home environment using the FibriCheck application Long-term: a successful detection of AF in a home environment can: Be the first step towards changing and improving the care pathway of the patient Induce therapeutic interventions in order to prevent strokes or other complications

Official Title
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Detection of the Common Arrhythmia Atrial Fibrillation in Different Patient Target Groups Using the FibriCheck Smartphone Application

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Diagnostic Test: FibriCheck


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Group 1: Patients without structural heart disease Age 65 and older CHADSVASc score of 2 or more (including congestive heart failure, hypertension, age, diabetes, previous stroke, vascular disease and sex) Comorbidities such as: coronary artery disease, kidney insufficiency, sleep apnea or symptomatic complaints with negative Holter in the past Group 2: Patients with structural heart disease Age 65 and older CHADSVASc score of 2 or more Left atrial volume indexed for body surface area (BSA) of 34 ml/m² or more, or left atrial diameter > 5 cm And any of the following indicators: Diastolic dysfunction of at least grade 2 with restrictive filling (E/A 2 or more) or disturbed relaxation (E/A 0.8) and with E/e' septal 15 or more (E/e' lateral 10 or more) or tricuspid insufficiency (TI) of 2.8 m/s or more At least mitral insufficiency (grade 2/3 or 3/3) or mitral stenosis Hypertrophic (obstructive) cardiomyopathy Group 3: Patients with high risk parameters for AF development Age 65 or more General Medical Record in the participating practice A 5-year risk of AF of at least 10% according to the CHARGE-AF risk score Group 4: Patients post-cryptogenic stroke or TIA - Experienced a cryptogenic TIA or stroke in the past year since the start of the study Group 5: Patients post-cardioversion therapy Confirmed AF patient based on 12-lead ECG Successful AF treatment using cardioversion (DCC or chemical) to convert the heart rhythm back to normal sinus rhythm Subjects are older than 18 years Group 6: Patients post-ablation therapy Confirmed AF patient based on 12-lead ECG Successful AF treatment using ablation therapy to restore the heart rhythm back to sinus rhythm in the past 3 months Subjects are older than 18 years Exclusion Criteria: Non-native Dutch Pacemaker dependent heart rhythm Perniosis patient Intense callus formation Low adherence to protocol Tremor or Parkinson Signs of Alzheimer or dementia No self-care ability Known AF patient

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients without structural heart disease<br> | Diagnostic Test: FibriCheck<br>* Digital health application<br>|
| Patients with structural heart disease<br> | Diagnostic Test: FibriCheck<br>* Digital health application<br>|
| Patients with high risk parameters for AF development<br> | Diagnostic Test: FibriCheck<br>* Digital health application<br>|
| Patients post-cryptogenic stroke<br> | Diagnostic Test: FibriCheck<br>* Digital health application<br>|
| Patients post-cardioversion therapy<br> | Diagnostic Test: FibriCheck<br>* Digital health application<br>|
| Patients post-ablation therapy<br> | Diagnostic Test: FibriCheck<br>* Digital health application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of unknown atrial fibrillation |  | 31 December 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of recurrent atrial fibrillation |  | 31 December 2017 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary prevention, Secondary prevention, Clinical practice