Atrial Fibrillation
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTHeart 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_TESTHeart 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_TESTHeart 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_TESTHeart 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.
Sponsors
Ziekenhuis Oost-Limburg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cramer's V | 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. |
| Sensitivity | 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 | 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 | During the heart rhythm measurements | Proportion of correct classifications with the device of interest. Correct classification is provided by the 12-lead ECG. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive predictive value | During the heart rhythm measurements | Proportion of true positive tests out of all positive tests. |
| Negative predictive value | During the heart rhythm measurements | Proportion of true negative tests out of all negative tests. |
| Patient preference score (for the use of the diagnostic devices) | During the heart rhythm measurements | This score is a (1-5) ordinal result based on the VALIDATION study questionnaire. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity, specificity and Cramer's V using only measurements of sufficient quality for analysis | During the heart rhythm measurements | The proportion of true positive tests, true negative tests and the association of between the classification of the test devices and 12-lead ECG. |
Countries
Belgium
Outcome results
None listed