Atrial FibrillationVALIDATIONNCT06023290
Validation of Digital Heart Rhythm Devices in the Detection of Atrial Fibrillation
A study testing Heart rhythm measurements with Preventicus®, Heart rhythm measurements with FibriCheck® and Heart rhythm measurements with Apple Watch® in people with Atrial Fibrillation, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
The VALIDATION study aims to evaluate the performance of four state-of-the-art digital heart rhythm devices (Preventicus®, FibriCheck®, Apple Watch®, 6L Kardia Mobile®) for the detection of atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Heart rhythm measurements with Preventicus®, Heart rhythm measurements with FibriCheck® and Heart rhythm measurements with Apple Watch®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Jul 2023to 17 Nov 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient is an ambulatory cardiology patient.
- The patient is at least 18 years old.
- The patient is sinus or in atrial fibrillation.
- The patient is able to perform the study procedures together with the study assistant.
Who cannot join
- Patients with a pacemaker
- Inclusion in another clinical trial that may influence the results of this trial
- The patient is unable to comprehend the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The VALIDATION study aims to evaluate the performance of four state-of-the-art digital heart rhythm devices (Preventicus®, FibriCheck®, Apple Watch®, 6L Kardia Mobile®) for the detection of atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- Heart rhythm measurements with Preventicus®, Heart rhythm measurements with FibriCheck®, Heart rhythm measurements with Apple Watch®, Heart rhythm measurements with 6L Kardia Mobile®
- 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 Preventicus®Diagnostic test
The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.
Heart rhythm measurements with FibriCheck®Diagnostic test
The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.
Heart rhythm measurements with Apple Watch®Diagnostic test
The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.
Heart rhythm measurements with 6L Kardia Mobile®Diagnostic test
The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.
| Study group | Role | What they receive |
|---|---|---|
| Study population (single arm) | Other | Not described Receives: Diagnostic Test: Heart rhythm measurements with Preventicus®; Diagnostic Test: Heart rhythm measurements with FibriCheck®; Diagnostic Test: Heart rhythm measurements with Apple Watch®; Diagnostic Test: Heart rhythm measurements with 6L 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 the device of interest out of all patients with AF on the 12-lead ECG.
Measured: During the heart rhythm measurements
Specificity
Proportion of true negative tests with the device of interest out of all patients in sinus rhythm on the 12-lead ECG.
Measured: During the heart rhythm measurements
Accuracy
Proportion of correct classifications with the device of interest. Correct classification is provided by the 12-lead ECG.
Measured: During the heart rhythm measurements
Cramer's V
The association of between the classification by the device of interest versus the 12-lead ECG, expressed as Cramer's V.
Measured: During the heart rhythm measurements
Secondary outcomes (3)
Positive predictive value
Proportion of true positive tests out of all positive tests.
Measured: During the heart rhythm measurements
Negative predictive value
Proportion of true negative tests out of all negative tests.
Measured: During the heart rhythm measurements
Patient preference score (for the use of the diagnostic devices)
This score is a (1-5) ordinal result based on the VALIDATION study questionnaire.
Measured: During the heart rhythm measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start3 Jul 2023
- Primary completion27 Oct 2023
- Study completion17 Nov 2023
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 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
- NCT06023290
- Sponsor's protocol ID
- Z-2023023
- Acronym
- VALIDATION
- Status last verified
- Nov 2023
- First submitted
- 4 Jul 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Digital Heart Rhythm Devices in the Detection of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06023290
- Acronym / sponsor ID
- VALIDATION / Z-2023023
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 5 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.
The VALIDATION study aims to evaluate the performance of four state-of-the-art digital heart rhythm devices (Preventicus®, FibriCheck®, Apple Watch®, 6L Kardia Mobile®) for the detection of atrial fibrillation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population (single arm) | Other | Diagnostic Test: Heart rhythm measurements with Preventicus®, Diagnostic Test: Heart rhythm measurements with FibriCheck®, Diagnostic Test: Heart rhythm measurements with Apple Watch®, Diagnostic Test: Heart rhythm measurements with 6L Kardia Mobile® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient is an ambulatory cardiology patient.
- The patient is at least 18 years old.
- The patient is sinus or in atrial fibrillation.
- The patient is able to perform the study procedures together with the study assistant.
Key exclusion criteria (3 listed)
- Patients with a pacemaker
- Inclusion in another clinical trial that may influence the results of this trial
- The patient is unable to comprehend the informed consent.
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 Preventicus®The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard. | Diagnostic test | Study population (single arm) |
| Heart rhythm measurements with FibriCheck®The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard. | Diagnostic test | Study population (single arm) |
| Heart rhythm measurements with Apple Watch®The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard. | Diagnostic test | Study population (single arm) |
| Heart rhythm measurements with 6L Kardia Mobile®The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard. | Diagnostic test | Study population (single arm) |
Primary outcome
Sensitivity
Time frame: During the heart rhythm measurements
Proportion of true positives tests with the device of interest out of all patients with AF on the 12-lead ECG.
Specificity
Time frame: During the heart rhythm measurements
Proportion of true negative tests with the device of interest out of all patients in sinus rhythm on the 12-lead ECG.
Accuracy
Time frame: During the heart rhythm measurements
Proportion of correct classifications with the device of interest. Correct classification is provided by the 12-lead ECG.
Cramer's V
Time frame: During the heart rhythm measurements
The association of between the classification by the device of interest versus the 12-lead ECG, expressed as Cramer's V.
3 secondary outcomes
Positive predictive value
Time frame: During the heart rhythm measurements
Negative predictive value
Time frame: During the heart rhythm measurements
Patient preference score (for the use of the diagnostic devices)
Time frame: During the heart rhythm measurements
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 1 Dec 2023.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
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
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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 Preventicus®, Heart rhythm measurements with FibriCheck® and Heart rhythm measurements with Apple Watch® 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 1 Dec 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: During the heart rhythm measurements). The study lists 4 primary outcomes in all. 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 1 Dec 2023.