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Status unknownNCT04613544Updated Nov 3, 2020

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

An observational study in Atrial Fibrillation, sponsored by Cardiokol Ltd. Status unknown at 2 sites in Israel. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2020-11-03.

Sponsored by Cardiokol Ltd · Observational

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 120 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Atrial Fibrillation

Browse trials for

03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 400 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

This is the only study on the registry with Cardiokol Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Atrial Fibrillation Diagnosed

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • Atrial Fibrillation

    Atrial fibrillation diagnosed patients.

    Device: Voice Assist Arrhythmia Monitoring (VAAM)

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.

06

What researchers measure

Primary outcomes

  1. Safety Assessment

    related Adverse device effect

    Time frame: 6 weeks

Secondary outcomes

  1. Usability

    Assessment of User Experience and User Interface

    Time frame: 6 weeks

  2. Effectivness

    application specificity and sensitivity

    Time frame: 6 wweeks

07

Study locations

2 of 2 sites recruiting
  • Meir Medical Center
    Kfar Saba, Israel
    Recruiting
  • Rabin Medical Center
    Petach tikva, Israel
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04613544
Lead sponsor
Cardiokol Ltd
Responsible party
Sponsor
First posted
Nov 3, 2020
Start date
Apr 7, 2020
Primary completion
Aug 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Nov 3, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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