Atrial Fibrillation
Conditions
Brief summary
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
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
Interventions
DEVICEVoice Assist Arrhythmia Monitoring (VAAM)
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.
Sponsors
Cardiokol Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
1. Female and male at age of ≥18 years and above. 2. All AF types Or Medical history of Cryptogenic stroke. 3. Ability and willingness to sign an informed consent form
Exclusion criteria
1. Subjects with implanted cardiac defibrillators or pacemakers neurostimulators and/or body worn medical devices such as insulin pumps. 2. Subjects diagnosed with any heart arrhythmias other than A-Fib, except for PVC. 3. Patient who underwent cardioversion or ablation in the last year and is in stable sinus rhythm. 4. Women who are pregnant or breastfeeding (women of child-bearing potential must provide a declaration stating that they are not pregnant) 5. Tremor or Parkinson's disease 6. Current hoarseness 7. Barriers for communication and lack of capability to execute the handlings required for this study. 8. Subjects who are currently enrolled in another clinical investigation. Parallel Enrollment to a non-interventional study is permitted.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment | 6 weeks | related Adverse device effect |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability | 6 weeks | Assessment of User Experience and User Interface |
| Effectivness | 6 wweeks | application specificity and sensitivity |
Countries
Israel
Outcome results
None listed