Atrial FibrillationRELATION PPGNCT06028893
REal-worLd vAlidaTION of PhotoPlehtysmoGraphy (for Atrial Fibrillation Detection)
A study testing Heart rhythm measurements with FibriCheck® and Heart rhythm measurements with Kardia Mobile® in people with Atrial Fibrillation, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
Mobile health solutions for rhythm monitoring (e.g. atrial fibrillation detection) using photoplethysmography (PPG) technology on a smartphone have been developed. This study validates the performance of a digital health application (FibriCheck®) using PPG technology on a smartphone against a single-lead ECG device… 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?
- Heart rhythm measurements with FibriCheck® and Heart rhythm measurements with Kardia Mobile®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2022to 31 Aug 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is scheduled for an ablation procedure for AF, at least 4 weeks after the inclusion.
- Subject provides informed consent.
- Subject understands and agrees to comply with planned study procedures.
- Subject is able to perform measurements of the heart rhythm using the FibriCheck application at home.
Who cannot join
- Insufficient cognitive or comprehensive level of Dutch to participate to the trial.
- No access to a smartphone or unable to perform FibriCheck measurements at home.
- Pacemaker.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Real-World Validation Study of Intermittent Photoplethysmography Based Rhythm Monitoring for Atrial Fibrillation Detection
Mobile health solutions for rhythm monitoring (e.g. atrial fibrillation detection) using photoplethysmography (PPG) technology on a smartphone have been developed. This study validates the performance of a digital health application (FibriCheck®) using PPG technology on a smartphone against a single-lead ECG device (Kardia Mobile®).
- Conditions
- Atrial Fibrillation
- Being tested
- Heart rhythm measurements with FibriCheck®, Heart rhythm measurements with Kardia Mobile®
- Keywords
- Atrial Fibrillation, Photoplethysmography, Single-lead ECG, Electrocardiogram, Digital Health
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rhythm measurements with FibriCheck®Diagnostic test
Measurements are performed twice daily, starting 4 weeks before a pulmonary vein isolation procedure (PVI) and ending 4 weeks after the PVI.
Heart rhythm measurements with Kardia Mobile®Diagnostic test
Measurements are performed immediately before and after every FibriCheck® measurement.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | All subjects will perform heart rhythm measurements with both diagnostic tests. Receives: Diagnostic Test: Heart rhythm measurements with FibriCheck®; Diagnostic Test: Heart rhythm measurements with Kardia Mobile® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.
Measured: Two months
Specificity
Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.
Measured: Two months
Overall accuracy (proportion of correct classifications)
Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.
Measured: Two months
Secondary outcomes (9)
Positive predictive value
Positive predictive value of FibriCheck® measurements relative to Kardia Mobile®.
Measured: Two months
Negative predictive value
Negative predictive value of FibriCheck® measurements relative to Kardia Mobile®.
Measured: Two months
Sensitivity by heart rate interval
Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.
Measured: Two months
Specificity by heart rate interval
Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.
Measured: Two months
Accuracy by heart rate interval
Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.
Measured: Two months
Proportion of PPG measurements of insufficient quality for rhythm analysis
PPG measurements by FibriCheck®.
Measured: Two months
Proportion of ECG measurements of insufficient quality for rhythm analysis
ECG measurements by Kardia Mobile®.
Measured: Two months
Proportion of PPG measurements of insufficient quality for rhythm analysis by heart rate interval
PPG measurements by FibriCheck®.
Measured: Two months
Proportion of ECG measurements of insufficient quality for rhythm analysis by heart rate interval
ECG measurements by Kardia Mobile®.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Dec 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028893
- Sponsor's protocol ID
- Z-2021058-2
- Acronym
- RELATION PPG
- Status last verified
- Aug 2023
- First submitted
- 31 Aug 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gruwez H, Ezzat D, Van Puyvelde T, Dhont S, Meekers E, Bruckers L, Wouters F, Kellens M, Van Herendael H, Rivero-Ayerza M, Nuyens D, Haemers P, Pison L. Real-world validation of smartphone-based photoplethysmography for rate and rhythm monitoring in atrial fibrillation. Europace. 2024 Mar 30;26(4):euae065. doi: 10.1093/europace/euae065.
PubMed 38630867
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Validation Study of Intermittent Photoplethysmography Based Rhythm Monitoring for Atrial Fibrillation Detection
- ClinicalTrials.gov ID
- NCT06028893
- Acronym / sponsor ID
- RELATION PPG / Z-2021058-2
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Photoplethysmography, Single-lead ECG, Electrocardiogram, Digital Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 8 Sep 2023 (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.
Mobile health solutions for rhythm monitoring (e.g. atrial fibrillation detection) using photoplethysmography (PPG) technology on a smartphone have been developed. This study validates the performance of a digital health application (FibriCheck®) using PPG technology on a smartphone against a single-lead ECG device (Kardia Mobile®).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Diagnostic Test: Heart rhythm measurements with FibriCheck®, Diagnostic Test: Heart rhythm measurements with Kardia Mobile®All subjects will perform heart rhythm measurements with both diagnostic tests. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is scheduled for an ablation procedure for AF, at least 4 weeks after the inclusion.
- Subject provides informed consent.
- Subject understands and agrees to comply with planned study procedures.
- Subject is able to perform measurements of the heart rhythm using the FibriCheck application at home.
Key exclusion criteria (3 listed)
- Insufficient cognitive or comprehensive level of Dutch to participate to the trial.
- No access to a smartphone or unable to perform FibriCheck measurements at home.
- Pacemaker.
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 |
|---|---|---|
| Heart rhythm measurements with FibriCheck®Measurements are performed twice daily, starting 4 weeks before a pulmonary vein isolation procedure (PVI) and ending 4 weeks after the PVI. | Diagnostic test | Study group |
| Heart rhythm measurements with Kardia Mobile®Measurements are performed immediately before and after every FibriCheck® measurement. | Diagnostic test | Study group |
Primary outcome
Sensitivity
Time frame: Two months
Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.
Specificity
Time frame: Two months
Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.
Overall accuracy (proportion of correct classifications)
Time frame: Two months
Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.
9 secondary outcomes
Positive predictive value
Time frame: Two months
Negative predictive value
Time frame: Two months
Sensitivity by heart rate interval
Time frame: Two months
Specificity by heart rate interval
Time frame: Two months
Accuracy by heart rate interval
Time frame: Two months
Proportion of PPG measurements of insufficient quality for rhythm analysis
Time frame: Two months
Proportion of ECG measurements of insufficient quality for rhythm analysis
Time frame: Two months
Proportion of PPG measurements of insufficient quality for rhythm analysis by heart rate interval
Time frame: Two months
Proportion of ECG measurements of insufficient quality for rhythm analysis by heart rate interval
Time frame: Two months
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 26 Oct 2023.
- Derived from this study: PubMed 38630867Gruwez H, Ezzat D, Van Puyvelde T, Dhont S, Meekers E, Bruckers L, Wouters F, Kellens M, Van Herendael H, Rivero-Ayerza M, Nuyens D, Haemers P, Pison L. Real-world validation of smartphone-based photoplethysmography for rate and rhythm monitoring in atrial fibrillation. Europace. 2024 Mar 30;26(4):euae065. doi: 10.1093/europace/euae065.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart rhythm measurements with FibriCheck® and Heart rhythm measurements with Kardia Mobile® in people with Atrial Fibrillation, run by Ziekenhuis Oost-Limburg at 1 site 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 4 inclusion and 3 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 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Sensitivity (time frame: Two months). The study lists 3 primary outcomes in all. 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 NCT06028893, 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 26 Oct 2023.