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

Cardiokol

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Device: Voice Assist Arrhythmia Monitoring (VAAM)

Study type: Observational

Funder types: Industry

Identifiers

NCT04613544

CLN-120

Details and patient eligibility

About

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.

Full 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

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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.

Trial design

400 participants in 1 patient group

Atrial Fibrillation

Description:

Atrial fibrillation diagnosed patients.

Treatment:

Device: Voice Assist Arrhythmia Monitoring (VAAM)