Atrial FibrillationFDA-AFNCT06282380
Fibricheck Detection cApabilities for Atrial Fibrillation
A study testing FibriCheck Mobile Application in people with Atrial Fibrillation, run by Qompium NV at 5 sites in 2 countries.
Trial summary
Evaluation of accuracy of the FibriCheck Mobile Application on various smartphone devices, compared to the reference diagnosis. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- FibriCheck Mobile Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 26 Feb 2024to 26 Jun 2024
- Phase
- Interventional
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States3 sites
Northwestern Medicin
Chicago, Illinois, 12251
New York Presebyterian Queens
New York, New York, 11355
OU Medicine College
Oklahoma City, Oklahoma, 73001
Belgium2 sites
University Hospital Antwerp
Antwerp, 2000
Ziekenhuis Oost-Limburg
Genk, 3600
About this study
Official title: Fibricheck Detection cApabilities for Atrial Fibrillation - a Multicenter Validation Study
Evaluation of accuracy of the FibriCheck Mobile Application on various smartphone devices, compared to the reference diagnosis.
- Conditions
- Atrial Fibrillation
- Being tested
- FibriCheck Mobile Application
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibriCheck Mobile ApplicationDevice
PPG measurement with reference diagnosis
| Study group | Role | What they receive |
|---|---|---|
| FibriCheck Mobile Application measurements | Other | Participants will perform one measurement using the FibriCheck Mobile Application and the result will be compared with the ground truth. Receives: Device: FibriCheck Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the FibriCheck Mobile Application
Accuracy based on the reference diagnosis
Measured: Through study completion: 1 day
Secondary outcomes (2)
Sensitivity of the FibriCheck Mobile Application
Sensitivity based on the reference diagnosis
Measured: Through study completion: 1 day
Specificity of the FibriCheck Mobile Application
Specificity based on the reference diagnosis
Measured: Through study completion: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start26 Feb 2024
- Primary completion26 Jun 2024
- Study completion26 Jun 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qompium NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282380
- Sponsor's protocol ID
- FDA-AF study
- Acronym
- FDA-AF
- Status last verified
- Jun 2024
- First submitted
- 19 Feb 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibricheck Detection cApabilities for Atrial Fibrillation - a Multicenter Validation Study
- ClinicalTrials.gov ID
- NCT06282380
- Acronym / sponsor ID
- FDA-AF / FDA-AF study
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Qompium NVIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 28 Feb 2024 (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.
Evaluation of accuracy of the FibriCheck Mobile Application on various smartphone devices, compared to the reference diagnosis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FibriCheck Mobile Application measurements | Other | Device: FibriCheck Mobile ApplicationParticipants will perform one measurement using the FibriCheck Mobile Application and the result will be compared with the ground truth. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| FibriCheck Mobile ApplicationPPG measurement with reference diagnosis | Device | FibriCheck Mobile Application measurements |
Primary outcome
Accuracy of the FibriCheck Mobile Application
Time frame: Through study completion: 1 day
Accuracy based on the reference diagnosis
2 secondary outcomes
Sensitivity of the FibriCheck Mobile Application
Time frame: Through study completion: 1 day
Specificity of the FibriCheck Mobile Application
Time frame: Through study completion: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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RecruitingPhase 2
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Atrial Fibrillation (AF)
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FibriCheck Mobile Application in people with Atrial Fibrillation, run by Qompium NV at 5 sites in 2 countries.
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 4 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: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the FibriCheck Mobile Application (time frame: Through study completion: 1 day). 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 27 Jun 2024.