Atrial FibrillationNCT03509493
Detection of Atrial Fibrillation in Different Patient Target Groups Using the FibriCheck Smartphone Application
An observational study of Atrial Fibrillation, run by Qompium NV at 8 sites in Belgium.
Trial summary
FibriCheck is a Conformité Européenne (CE)-approved (class IIa) medically diagnostic application that allows for heart rhythm registrations based on an optical signal captured via the smartphone camera. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- FibriCheck
- How many people
- 465 participants
- Where
- 8 sitesBelgium
- Study dates
- 1 Jun 2017to 31 Dec 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All eligible patients are included in the corresponding group
Who may be able to join
- Group 1: Patients without structural heart disease
- Age 65 and older
- CHADSVASc score of 2 or more (including congestive heart failure, hypertension, age, diabetes, previous stroke, vascular disease and sex)
- Comorbidities such as: coronary artery disease, kidney insufficiency, sleep apnea or symptomatic complaints with negative Holter in the past
- Group 2: Patients with structural heart disease
- Age 65 and older
Show all 26Show fewer
- CHADSVASc score of 2 or more
- Left atrial volume indexed for body surface area (BSA) of 34 ml/m² or more, or left atrial diameter > 5 cm
- And any of the following indicators:
- Diastolic dysfunction of at least grade 2 with restrictive filling (E/A 2 or more) or disturbed relaxation (E/A 0.8) and with E/e' septal 15 or more (E/e' lateral 10 or more) or tricuspid insufficiency (TI) of 2.8 m/s or more
- At least mitral insufficiency (grade 2/3 or 3/3) or mitral stenosis
- Hypertrophic (obstructive) cardiomyopathy
- Group 3: Patients with high risk parameters for AF development
- Age 65 or more
- General Medical Record in the participating practice
- A 5-year risk of AF of at least 10% according to the CHARGE-AF risk score
- Group 4: Patients post-cryptogenic stroke or TIA
- Experienced a cryptogenic TIA or stroke in the past year since the start of the study
- Group 5: Patients post-cardioversion therapy
- Confirmed AF patient based on 12-lead ECG
- Successful AF treatment using cardioversion (DCC or chemical) to convert the heart rhythm back to normal sinus rhythm
- Subjects are older than 18 years
- Group 6: Patients post-ablation therapy
- Confirmed AF patient based on 12-lead ECG
- Successful AF treatment using ablation therapy to restore the heart rhythm back to sinus rhythm in the past 3 months
- Subjects are older than 18 years
Who cannot join
- Non-native Dutch
- Pacemaker dependent heart rhythm
- Perniosis patient
- Intense callus formation
- Low adherence to protocol
- Tremor or Parkinson
Show all 9Show fewer
- Signs of Alzheimer or dementia
- No self-care ability
- Known AF patient
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Belgium8 sites
Ziekenhuis Oost Limburg
Genk, Limburg, 3600
AZ Maria Middelares
Ghent, Oost-Vlaanderen, 9000
Jessa Ziekenhuis
Hasselt, Limburg, 3500
HAK Hooglede
Hooglede, West-Vlaanderen, 8830
Jan Yperman Ziekenhuis
Ieper, West-Vlaanderen, 8900
AZ Groeninge
Kortrijk, West-Vlaanderen, 8500
AC Huisartsengeneeskunde KU Leuven
Leuven, Vlaams-Brabant, 3000
AZ Delta Ziekenhuis
Roeselare, West-Vlaanderen, 8800
About this study
Official title: Detection of the Common Arrhythmia Atrial Fibrillation in Different Patient Target Groups Using the FibriCheck Smartphone Application
FibriCheck is a Conformité Européenne (CE)-approved (class IIa) medically diagnostic application that allows for heart rhythm registrations based on an optical signal captured via the smartphone camera. FibriCheck is only available on prescription causing the physician to stay in the 'driving seat' and the application distribution to be traced.
By using FibriCheck, a medically validated smartphone application, daily rhythm measurements can be performed using only the smartphone of the patient. This allows for the heart rhythm to be registered and monitored in a home environment and the data to be automatically sent to the physician. This enables the implementation of FibriCheck in two types of scenarios:
- Scenario 1: the follow-up of patients with high risk parameters for AF development for primary and secondary prevention, whereby detection of AF will result in therapeutic intervention
- Scenario 2: the realisation of monitoring of the heart rhythm of patients post intervention in a home environment
Read the detailed description
Atrial fibrillation (AF) is the most common heart rhythm disorder affecting 50 million people in Europe and the U.S. It is associated with an increasing mortality and risk for transient cerebrovascular incidents and dementia. De novo AF is in most cases asymptomatic and paroxysmal, causing the diagnosis to be made either by chance or in response to an incident. This drastically impacts the quality of life of the patient and is accompanied with a high socio-economic cost. Guidelines indicate that anticoagulation in patients diagnosed with AF is a cost-effective solution for the prevention of strokes.
In addition, depending on the target group, patients identified with AF can receive therapy in order to control the heart rhythm. These procedures (cardioversion and ablation) often result in follow-up consultations that can be avoided if the heart rhythm can be monitored remotely.
By using FibriCheck, a medically validated smartphone application, daily rhythm measurements can be performed using only the smartphone of the patient. This allows for the heart rhythm to be registered and monitored in a home environment and the data to be automatically sent to the physician. This enables the implementation of FibriCheck in two types of scenarios:
- Scenario 1: the follow-up of patients with high risk parameters for AF development for primary and secondary prevention, whereby detection of AF will result in therapeutic intervention
- Scenario 2: the realisation of monitoring of the heart rhythm of patients post intervention in a home environment
The follow-up of patients is still driven by the treating physician(s). The objective is to implement a correct and successful process management allowing a smooth implementation of "an application on prescription".
Short- and long-term benefits the project wants to prove:
Short-term:
- AF can successfully be detected in a home environment using the FibriCheck application
Long-term: a successful detection of AF in a home environment can:
- Be the first step towards changing and improving the care pathway of the patient
- Induce therapeutic interventions in order to prevent strokes or other complications
- Conditions
- Atrial Fibrillation
- Being tested
- FibriCheck
- Keywords
- Primary prevention, Secondary prevention, Clinical practice
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibriCheckDiagnostic test
Digital health application
| Study group | Role | What they receive |
|---|---|---|
| Patients without structural heart disease | Not described Receives: Diagnostic Test: FibriCheck | |
| Patients with structural heart disease | Not described Receives: Diagnostic Test: FibriCheck | |
| Patients with high risk parameters for AF development | Not described Receives: Diagnostic Test: FibriCheck | |
| Patients post-cryptogenic stroke | Not described Receives: Diagnostic Test: FibriCheck | |
| Patients post-cardioversion therapy | Not described Receives: Diagnostic Test: FibriCheck | |
| Patients post-ablation therapy | Not described Receives: Diagnostic Test: FibriCheck |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of unknown atrial fibrillation
Measured: 31 December 2017
Secondary outcomes (1)
Detection of recurrent atrial fibrillation
Measured: 31 December 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start1 Jun 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 465 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
- NCT03509493
- Sponsor's protocol ID
- 1
- Status last verified
- Apr 2018
- First submitted
- 24 Apr 2018
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Beerten SG, Proesmans T, Vaes B. A Heart Rate Monitoring App (FibriCheck) for Atrial Fibrillation in General Practice: Pilot Usability Study. JMIR Form Res. 2021 Apr 7;5(4):e24461. doi: 10.2196/24461.
PubMed 33825692
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of the Common Arrhythmia Atrial Fibrillation in Different Patient Target Groups Using the FibriCheck Smartphone Application
- ClinicalTrials.gov ID
- NCT03509493
- Acronym / sponsor ID
- 1
- Conditions
- Atrial Fibrillation
- Keywords
- Primary prevention, Secondary prevention, Clinical practice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- Qompium NVIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 26 Apr 2018 (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.
FibriCheck is a Conformité Européenne (CE)-approved (class IIa) medically diagnostic application that allows for heart rhythm registrations based on an optical signal captured via the smartphone camera. FibriCheck is only available on prescription causing the physician to stay in the 'driving seat' and the application distribution to be traced.
By using FibriCheck, a medically validated smartphone application, daily rhythm measurements can be performed using only the smartphone of the patient. This allows for the heart rhythm to be registered and monitored in a home environment and the data to be automatically sent to the physician. This enables the implementation of FibriCheck in two types of scenarios:
- Scenario 1: the follow-up of patients with high risk parameters for AF development for primary and secondary prevention, whereby detection of AF will result in therapeutic intervention
- Scenario 2: the realisation of monitoring of the heart rhythm of patients post intervention in a home environment
Detailed description
Atrial fibrillation (AF) is the most common heart rhythm disorder affecting 50 million people in Europe and the U.S. It is associated with an increasing mortality and risk for transient cerebrovascular incidents and dementia. De novo AF is in most cases asymptomatic and paroxysmal, causing the diagnosis to be made either by chance or in response to an incident. This drastically impacts the quality of life of the patient and is accompanied with a high socio-economic cost. Guidelines indicate that anticoagulation in patients diagnosed with AF is a cost-effective solution for the prevention of strokes.
In addition, depending on the target group, patients identified with AF can receive therapy in order to control the heart rhythm. These procedures (cardioversion and ablation) often result in follow-up consultations that can be avoided if the heart rhythm can be monitored remotely.
By using FibriCheck, a medically validated smartphone application, daily rhythm measurements can be performed using only the smartphone of the patient. This allows for the heart rhythm to be registered and monitored in a home environment and the data to be automatically sent to the physician. This enables the implementation of FibriCheck in two types of scenarios:
- Scenario 1: the follow-up of patients with high risk parameters for AF development for primary and secondary prevention, whereby detection of AF will result in therapeutic intervention
- Scenario 2: the realisation of monitoring of the heart rhythm of patients post intervention in a home environment
The follow-up of patients is still driven by the treating physician(s). The objective is to implement a correct and successful process management allowing a smooth implementation of "an application on prescription".
Short- and long-term benefits the project wants to prove:
Short-term:
- AF can successfully be detected in a home environment using the FibriCheck application
Long-term: a successful detection of AF in a home environment can:
- Be the first step towards changing and improving the care pathway of the patient
- Induce therapeutic interventions in order to prevent strokes or other complications
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Patients without structural heart disease | – | Diagnostic Test: FibriCheck |
| Patients with structural heart disease | – | Diagnostic Test: FibriCheck |
| Patients with high risk parameters for AF development | – | Diagnostic Test: FibriCheck |
| Patients post-cryptogenic stroke | – | Diagnostic Test: FibriCheck |
| Patients post-cardioversion therapy | – | Diagnostic Test: FibriCheck |
| Patients post-ablation therapy | – | Diagnostic Test: FibriCheck |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients are included in the corresponding group
Key inclusion criteria (26 listed)
- Group 1: Patients without structural heart disease
- Age 65 and older
- CHADSVASc score of 2 or more (including congestive heart failure, hypertension, age, diabetes, previous stroke, vascular disease and sex)
- Comorbidities such as: coronary artery disease, kidney insufficiency, sleep apnea or symptomatic complaints with negative Holter in the past
- Group 2: Patients with structural heart disease
Key exclusion criteria (9 listed)
- Non-native Dutch
- Pacemaker dependent heart rhythm
- Perniosis patient
- Intense callus formation
- Low adherence to protocol
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 |
|---|---|---|
| FibriCheckDigital health application | Diagnostic test | Patients post-ablation therapy, Patients post-cardioversion therapy, Patients post-cryptogenic stroke, Patients with high risk parameters for AF development, Patients with structural heart disease, Patients without structural heart disease |
Primary outcome
Detection of unknown atrial fibrillation
Time frame: 31 December 2017
1 secondary outcome
Detection of recurrent atrial fibrillation
Time frame: 31 December 2017
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 30 Apr 2018.
- Derived from this study: PubMed 33825692Beerten SG, Proesmans T, Vaes B. A Heart Rate Monitoring App (FibriCheck) for Atrial Fibrillation in General Practice: Pilot Usability Study. JMIR Form Res. 2021 Apr 7;5(4):e24461. doi: 10.2196/24461.
- Individual participant dataSharing planned: Undecided
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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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Qompium NV at 8 sites in Belgium.
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 26 inclusion and 9 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 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in 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?
Detection of unknown atrial fibrillation (time frame: 31 December 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03509493, which also lists 1 linked publication.
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 30 Apr 2018.