Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study population (single arm) | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Proportion of true positives tests with the device of interest out of all patients with AF on the 12-lead ECG. | 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. | During the heart rhythm measurements |
| Accuracy | Proportion of correct classifications with the device of interest. Correct classification is provided by the 12-lead ECG. | 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. | During the heart rhythm measurements |
| Measure | Description | Time Frame |
|---|---|---|
| Positive predictive value | Proportion of true positive tests out of all positive tests. | During the heart rhythm measurements |
| Negative predictive value | Proportion of true negative tests out of all negative tests. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, specificity and Cramer's V using only measurements of sufficient quality for analysis | The proportion of true positive tests, true negative tests and the association of between the classification of the test devices and 12-lead ECG. | During the heart rhythm measurements |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | Limburg | 3600 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 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. | During the heart rhythm measurements |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided