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

NCT ID: NCT04613544

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-07

Study Completion Date

2021-12-31

Brief Summary

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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

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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

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Atrial Fibrillation

Atrial fibrillation diagnosed patients.

Voice Assist Arrhythmia Monitoring (VAAM)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiokol Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status RECRUITING

Rabin Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Alex Omelchenko, MD

Role: primary

[email protected]
972-9-7472573

Gregory Golovchiner, MD

Role: primary

[email protected]
9723-9377107

Other Identifiers

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CLN-120

Identifier Type: -

Identifier Source: org_study_id