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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04613544
• Other study ID #: CLN-120
• Status: Recruiting
• Start date: April 7, 2020
• Est. completion date: December 2021

Study information

• Verified date: October 2020
• Source: Cardiokol Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Voice 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.

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center	Petach tikva

Sponsors (1)

Lead Sponsor	Collaborator
Cardiokol Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Assessment	related Adverse device effect	6 weeks
Secondary	Usability	Assessment of User Experience and User Interface	6 weeks
Secondary	Effectivness	application specificity and sensitivity	6 wweeks