Enhanced Diagnostics for Early Detection of Atrial Fibrillation - Prospective Validation

Study Overview
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Brief Summary
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Prospective, blinded, multicenter international trial to test the Preventicus Heartbeats App in a prospective cohort.

Detailed Description
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Introduction This algorithm was validated earlier in a clinical trial with retrospective Data. The results were published accordingly.The algorithm is implemented in the commercial App Preventicus Heartbeats. DETECT AF is designed as prospective follow up trial. Study design Prospective, blinded, multicenter international trial. Methods The subjects will be asked to position a smartphone on their index finger to allow their pulse curve to be recorded for five minutes. At the same time, an ecg will be recorded using an digital mobile ecg recorder as a reference. Data will be collected on person-related information, comorbidities and medication (estimated overall duration/patient <20 min). No follow-up is planned. Analogous to predecessor studies, the pulse wave curve data are coded with the patient's identification number (ID) and externally analyzed at Preventicus; based on the results, the subjects will be assigned to SR/AF groups. After evaluation of all files, the grouped results will be aggregated, unblinded and evaluated under monitoring. Primary target parameters are the app's sensitivity and specificity in correctly detecting atrial fibrillation compared to an automatically interpreted ECG. Secondary target parameters include the proportion of non-evaluable recordings in the overall study.

Official Title
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Enhanced Diagnostics for Early Detection of Atrial Fibrillation - Prospective Validation

Conditions
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Atrium; Fibrillation, Arrhythmia Atrial

Intervention / Treatment
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* Device: Five minutes puls wave recording


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of legal age, patients with either sinus rhythm (Group SR) or atrial fibrillation (Group AF) informed consent Exclusion Criteria: Legally incompetent persons

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| AF<br>Five minutes puls wave recording will be performed in patients in atrial fibrillation at time of recruitment | Device: Five minutes puls wave recording<br>* iPhone will be positioned on the index finger for five minutes to record a pulse wave<br>|
| SR<br>Five minutes puls wave recording will be performed in patients in sinus rhythm at time of recruitment | Device: Five minutes puls wave recording<br>* iPhone will be positioned on the index finger for five minutes to record a pulse wave<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correct detection of atrial fibrillation | iPhone will be positioned on the index finger for five minutes to record a pulse wave; Algorithm should correctly differentiate between AF patients and SR patients | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Rhythm monitoring, Cardiovascular App, m-health