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
1 other identifier
observational
400
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 7, 2020
CompletedFirst Submitted
Initial submission to the registry
October 28, 2020
CompletedFirst Posted
Study publicly available on registry
November 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedNovember 3, 2020
October 1, 2020
1.3 years
October 28, 2020
November 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Safety Assessment
related Adverse device effect
6 weeks
Secondary Outcomes (2)
Usability
6 weeks
Effectivness
6 wweeks
Study Arms (1)
Atrial Fibrillation
Atrial fibrillation diagnosed patients.
Interventions
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.
Eligibility Criteria
Atrial Fibrillation Diagnosed
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cardiokol Ltdlead
Study Sites (2)
Meir Medical Center
Kfar Saba, Israel
Rabin Medical Center
Petah Tikva, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2020
First Posted
November 3, 2020
Study Start
April 7, 2020
Primary Completion
August 1, 2021
Study Completion
December 1, 2021
Last Updated
November 3, 2020
Record last verified: 2020-10