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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial Fibrillation | Atrial fibrillation diagnosed patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voice Assist Arrhythmia Monitoring (VAAM) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment | related Adverse device effect | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Usability | Assessment of User Experience and User Interface | 6 weeks |
| Effectivness | application specificity and sensitivity | 6 wweeks |
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Inclusion Criteria:
Exclusion Criteria:
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Atrial Fibrillation Diagnosed
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Medical Center | Recruiting | Kfar Saba | Israel |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| Rabin Medical Center | Recruiting | Petah Tikva | Israel |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |