Fibricheck Detection cApabilities for Atrial Fibrillation
FDA-AF
1 other identifier
interventional
330
2 countries
5
Brief Summary
Evaluation of accuracy of the FibriCheck Mobile Application on various smartphone devices, compared to the reference diagnosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable atrial-fibrillation
Started Feb 2024
Shorter than P25 for not_applicable atrial-fibrillation
5 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
First Submitted
Initial submission to the registry
February 19, 2024
CompletedStudy Start
First participant enrolled
February 26, 2024
CompletedFirst Posted
Study publicly available on registry
February 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2024
CompletedJune 27, 2024
June 1, 2024
4 months
February 19, 2024
June 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Accuracy of the FibriCheck Mobile Application
Accuracy based on the reference diagnosis
Through study completion: 1 day
Secondary Outcomes (2)
Sensitivity of the FibriCheck Mobile Application
Through study completion: 1 day
Specificity of the FibriCheck Mobile Application
Through study completion: 1 day
Study Arms (1)
FibriCheck Mobile Application measurements
OTHERParticipants will perform one measurement using the FibriCheck Mobile Application and the result will be compared with the ground truth.
Interventions
PPG measurement with reference diagnosis
Eligibility Criteria
You may qualify if:
- At least 22 years old;
- Capable of independently performing FibriCheck recordings (researcher-observed);
- Cardiology patients, hospitalized/in-clinic or consulting the cardiac outpatient clinic, with or without a diagnosis of atrial fibrillation.
You may not qualify if:
- Individuals with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can influence the natural heart rhythm;
- Individuals enrolled in another clinical trial;
- Individuals with physical or medical characteristics that prevent them from successfully taking a measurement e.g. extreme callus (i.e., rough or thickened area of skin fingertip), tremor, cognitive impairment, Parkinson's disease;
- Pregnant and/or nursing women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Qompium NVlead
Study Sites (5)
Northwestern Medicin
Chicago, Illinois, 12251, United States
New York Presebyterian Queens
New York, New York, 11355, United States
OU Medicine College
Oklahoma City, Oklahoma, 73001, United States
University Hospital Antwerp
Antwerp, 2000, Belgium
Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2024
First Posted
February 28, 2024
Study Start
February 26, 2024
Primary Completion
June 26, 2024
Study Completion
June 26, 2024
Last Updated
June 27, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share