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

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel
    • Recruiting
    • Meir Medical Center
    • Contact: Alex Omelchenko, MD; Phone Number: 972-9-7472573; Email: alexom36@gmail.com
  • Petach tikva, Israel
    • Recruiting
    • Rabin Medical Center
    • Contact: Gregory Golovchiner, MD; Phone Number: 9723-9377107; Email: gregoryg@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 116 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Atrial Fibrillation Diagnosed

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Assessment	related Adverse device effect	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability	Assessment of User Experience and User Interface	6 weeks
Effectivness	application specificity and sensitivity	6 wweeks

Collaborators and Investigators

• Sponsor: Cardiokol Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CLN-120

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No