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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
126
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.
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.
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.
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium
Sensitivity
Proportion of true positives tests with the device of interest out of all patients with AF on the 12-lead ECG.
Time frame: 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.
Time frame: During the heart rhythm measurements
Accuracy
Proportion of correct classifications with the device of interest. Correct classification is provided by the 12-lead ECG.
Time frame: 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.
Time frame: During the heart rhythm measurements
Positive predictive value
Proportion of true positive tests out of all positive tests.
Time frame: During the heart rhythm measurements
Negative predictive value
Proportion of true negative tests out of all negative tests.
Time frame: 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.
Time frame: During the heart rhythm measurements
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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.