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

• Conditions: Atrial Fibrillation
• Interventions: Device: Voice Assist Arrhythmia Monitoring (VAAM)

• Registration Number: NCT04613544
• Lead Sponsor: Cardiokol Ltd

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

Study Timeline

• Study Start: 2020-04-07
• Status Verified: 2020-10
• Study First Submitted: 2020-10-28
• Study First Submitted QC: 2020-11-02
• Last Update Submitted: 2020-11-02
• Study First Posted: 2020-11-03
• Last Update Posted: 2020-11-03
• Primary Completion: 2021-08
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Atrial Fibrillation	Voice Assist Arrhythmia Monitoring (VAAM)	Atrial fibrillation diagnosed patients.

Primary Outcome Measures

Name	Time	Method
Safety Assessment	6 weeks	related Adverse device effect

Secondary Outcome Measures

Name	Time	Method
Usability	6 weeks	Assessment of User Experience and User Interface
Effectivness	6 wweeks	application specificity and sensitivity

Trial Locations

Locations (2)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel

Rabin Medical Center; 🇮🇱 Petach tikva, Israel