Validation of Digital Heart Rhythm Devices in the Detection of Atrial Fibrillation

Study Overview
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Brief Summary
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The VALIDATION study aims to evaluate the performance of four state-of-the-art digital heart rhythm devices (Preventicus®, FibriCheck®, Apple Watch®, 6L Kardia Mobile®) for the detection of atrial fibrillation.

Official Title
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Validation of Digital Heart Rhythm Devices in the Detection of Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Diagnostic Test: Heart rhythm measurements with Preventicus®
* Diagnostic Test: Heart rhythm measurements with FibriCheck®
* Diagnostic Test: Heart rhythm measurements with Apple Watch®
* Diagnostic Test: Heart rhythm measurements with 6L Kardia Mobile®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is an ambulatory cardiology patient. The patient is at least 18 years old. The patient is sinus or in atrial fibrillation. The patient is able to perform the study procedures together with the study assistant. Exclusion Criteria: Patients with a pacemaker Inclusion in another clinical trial that may influence the results of this trial The patient is unable to comprehend the informed consent.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study population (single arm)<br> | Diagnostic Test: Heart rhythm measurements with Preventicus®<br>* The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.<br>Diagnostic Test: Heart rhythm measurements with FibriCheck®<br>* The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.<br>Diagnostic Test: Heart rhythm measurements with Apple Watch®<br>* The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.<br>Diagnostic Test: Heart rhythm measurements with 6L Kardia Mobile®<br>* The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Proportion of true positives tests with the device of interest out of all patients with AF on the 12-lead ECG. | During the heart rhythm measurements | 
| Specificity | Proportion of true negative tests with the device of interest out of all patients in sinus rhythm on the 12-lead ECG. | During the heart rhythm measurements | 
| Accuracy | Proportion of correct classifications with the device of interest. Correct classification is provided by the 12-lead ECG. | During the heart rhythm measurements | 
| Cramer's V | The association of between the classification by the device of interest versus the 12-lead ECG, expressed as Cramer's V. | During the heart rhythm measurements | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value | Proportion of true positive tests out of all positive tests. | During the heart rhythm measurements | 
| Negative predictive value | Proportion of true negative tests out of all negative tests. | During the heart rhythm measurements | 
| Patient preference score (for the use of the diagnostic devices) | This score is a (1-5) ordinal result based on the VALIDATION study questionnaire. | During the heart rhythm measurements |