Assess Safety, Efficacy and Usability of Application for Atrial Fibrillation Vocal Marker

Study Overview
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Brief Summary
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Voice Assist Arrhythmia Monitoring (VAAM) is an application running on smartphones and/or landline phones that performs vocal tests for the monitoring of abnormalities in the heart rhythm.

Detailed Description
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Following ICF signature and process and eligibility confirmation, subject will have a training session to assure correct application use. The subjects will be asked to pronounce few vowels 3 times a day to be evaluated by the application analysis algorithm at the patient natural environment. At the same time, a single lead ECG system will be recorded synchronously ECG for reference with the use of dedicated recording device

Official Title
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A Prospective, Open Label, Multi-Center, Pilot Study to Assess Safety, Efficacy and Usability of Application for Atrial Fibrillation Vocal Marker

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Voice Assist Arrhythmia Monitoring (VAAM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female and male at age of ≥18 years and above. All AF types Or Medical history of Cryptogenic stroke. Ability and willingness to sign an informed consent form Exclusion Criteria: Subjects with implanted cardiac defibrillators or pacemakers neurostimulators and/or body worn medical devices such as insulin pumps. Subjects diagnosed with any heart arrhythmias other than A-Fib, except for PVC. Patient who underwent cardioversion or ablation in the last year and is in stable sinus rhythm. Women who are pregnant or breastfeeding (women of child-bearing potential must provide a declaration stating that they are not pregnant) Tremor or Parkinson's disease Current hoarseness Barriers for communication and lack of capability to execute the handlings required for this study. Subjects who are currently enrolled in another clinical investigation. Parallel Enrollment to a non-interventional study is permitted.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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 |
| --- | --- |
| Atrial Fibrillation<br>Atrial fibrillation diagnosed patients. | Device: Voice Assist Arrhythmia Monitoring (VAAM)<br>* application flag the potential occurrence of irregular heart rhythms suggestive of atrial fibrillation (AF) and notify to further investigate the occurrence of the suspected AF episode by prompting user to initiate ECG test to confirm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment | related Adverse device effect | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability | Assessment of User Experience and User Interface | 6 weeks | 
| Effectivness | application specificity and sensitivity | 6 wweeks |