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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04613544
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Cardiokol Ltd

Study Description
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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.

Condition or disease Intervention/treatment
Atrial Fibrillation Device: Voice Assist Arrhythmia Monitoring (VAAM)

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 Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Open Label, Multi-Center, Pilot Study to Assess Safety, Efficacy and Usability of Application for Atrial Fibrillation Vocal Marker
Actual Study Start Date : April 7, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Atrial Fibrillation
Atrial fibrillation diagnosed patients.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety Assessment [ Time Frame: 6 weeks ]
    related Adverse device effect


Secondary Outcome Measures :
  1. Usability [ Time Frame: 6 weeks ]
    Assessment of User Experience and User Interface

  2. Effectivness [ Time Frame: 6 wweeks ]
    application specificity and sensitivity


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Atrial Fibrillation Diagnosed
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613544


Locations
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Israel
Meir Medical Center Recruiting
Kfar Saba, Israel
Contact: Alex Omelchenko, MD    972-9-7472573    alexom36@gmail.com   
Rabin Medical Center Recruiting
Petach tikva, Israel
Contact: Gregory Golovchiner, MD    9723-9377107    gregoryg@clalit.org.il   
Sponsors and Collaborators
Cardiokol Ltd
More Information
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Responsible Party: Cardiokol Ltd
ClinicalTrials.gov Identifier: NCT04613544    
Other Study ID Numbers: CLN-120
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes