Atrial Fibrillation Clinical Trial
— VALIDATIONOfficial title:
Validation of Digital Heart Rhythm Devices in the Detection of Atrial Fibrillation
Verified date | November 2023 |
Source | Ziekenhuis Oost-Limburg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 126 |
Est. completion date | November 17, 2023 |
Est. primary completion date | October 27, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Ziekenhuis Oost-Limburg | Genk | Limburg |
Lead Sponsor | Collaborator |
---|---|
Ziekenhuis Oost-Limburg |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Accuracy | Proportion of correct classifications with the device of interest. Correct classification is provided by the 12-lead ECG. | During the heart rhythm measurements | |
Primary | 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 | |
Secondary | Positive predictive value | Proportion of true positive tests out of all positive tests. | During the heart rhythm measurements | |
Secondary | Negative predictive value | Proportion of true negative tests out of all negative tests. | During the heart rhythm measurements | |
Secondary | 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 |
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