Atrial FibrillationNCT04613544
Assess Safety, Efficacy and Usability of Application for Atrial Fibrillation Vocal Marker
An observational study of Atrial Fibrillation, run by Cardiokol Ltd at 2 sites in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Voice Assist Arrhythmia Monitoring (VAAM)
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 2 sitesIsrael
- Study dates
- 7 Apr 2020to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Atrial Fibrillation Diagnosed
Who may be able to join
- Female and male at age of ≥18 years and above.
- All AF types Or Medical history of Cryptogenic stroke.
- Ability and willingness to sign an informed consent form
Who cannot join
- Subjects with implanted cardiac defibrillators or pacemakers neurostimulators and/or body worn medical devices such as insulin pumps.
- Subjects diagnosed with any heart arrhythmias other than A-Fib, except for PVC.
- Patient who underwent cardioversion or ablation in the last year and is in stable sinus rhythm.
- Women who are pregnant or breastfeeding (women of child-bearing potential must provide a declaration stating that they are not pregnant)
- Tremor or Parkinson's disease
- Current hoarseness
- Barriers for communication and lack of capability to execute the handlings required for this study.
- Subjects who are currently enrolled in another clinical investigation. Parallel Enrollment to a non-interventional study is permitted.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Meir Medical Center
Kfar Saba
Alex Omelchenko, MD, 972-9-7472573, alexom36@gmail.com
- Recruiting
Rabin Medical Center
Petah Tikva
Gregory Golovchiner, MD, 9723-9377107, gregoryg@clalit.org.il
About this study
Official title: A Prospective, Open Label, Multi-Center, Pilot Study to Assess Safety, Efficacy and Usability of Application for Atrial Fibrillation Vocal Marker
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
- Conditions
- Atrial Fibrillation
- Being tested
- Voice Assist Arrhythmia Monitoring (VAAM)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice Assist Arrhythmia Monitoring (VAAM)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Atrial Fibrillation | Atrial fibrillation diagnosed patients. Receives: Device: Voice Assist Arrhythmia Monitoring (VAAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessment
related Adverse device effect
Measured: 6 weeks
Secondary outcomes (2)
Usability
Assessment of User Experience and User Interface
Measured: 6 weeks
Effectivness
application specificity and sensitivity
Measured: 6 wweeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start7 Apr 2020
- Primary completionAug 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiokol Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613544
- Sponsor's protocol ID
- CLN-120
- Status last verified
- Oct 2020
- First submitted
- 28 Oct 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Multi-Center, Pilot Study to Assess Safety, Efficacy and Usability of Application for Atrial Fibrillation Vocal Marker
- ClinicalTrials.gov ID
- NCT04613544
- Acronym / sponsor ID
- CLN-120
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Cardiokol LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation | – | Device: Voice Assist Arrhythmia Monitoring (VAAM)Atrial fibrillation diagnosed patients. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Atrial Fibrillation Diagnosed
Key inclusion criteria (3 listed)
- Female and male at age of ≥18 years and above.
- All AF types Or Medical history of Cryptogenic stroke.
- Ability and willingness to sign an informed consent form
Key exclusion criteria (8 listed)
- Subjects with implanted cardiac defibrillators or pacemakers neurostimulators and/or body worn medical devices such as insulin pumps.
- Subjects diagnosed with any heart arrhythmias other than A-Fib, except for PVC.
- Patient who underwent cardioversion or ablation in the last year and is in stable sinus rhythm.
- Women who are pregnant or breastfeeding (women of child-bearing potential must provide a declaration stating that they are not pregnant)
- Tremor or Parkinson's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Atrial Fibrillation |
Primary outcome
Safety Assessment
Time frame: 6 weeks
related Adverse device effect
2 secondary outcomes
Usability
Time frame: 6 weeks
Effectivness
Time frame: 6 wweeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Cardiokol Ltd at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Assessment (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.