MMT-Corsano 287 CardioWatch

Patients will be recruited from the outpatient clinics of Cardiology Centers of the Netherlands (CCN). Eligible patients have been scheduled by their treating cardiologist for a resting ECG. Participants will wear a smartwatch, measuring pulse rate, while simultaneously having a 5 minute resting ECG recorded. In this study we will investigate the efficacy and safety of the smartwatch, intended to monitor pulse rate and RR-intervals, based on a comparison to the classical resting ECG recording. Raw data in XML-format from both smartwatch and ECG-recording will be compared on heart rate and RR-intervals.

The sample size calculation was done with PASS (version 15.0.2) for two-sided exact Clopper-Pearson 95% confidence intervals for one proportion (sensitivity). A sample size of 30'000 heart beats (thus 100 patients with approx. 300 heart beats each per 5 minutes) produces a two-sided 95% confidence interval with a width equal to 0.007 and a lower limit of the 95% confidence interval of 0.897 when the sample proportion is 0.900. It is expected that the width of the confidence interval will be slightly wider when a general estimating equation model (GEE) is used as analysis that takes into account that observations are correlated within subjects.

The expected sensitivity of the CardioWatch 287 is 95%, as compared to the classical resting ECG recording. Sensitivity is defined as the percentage of HR and RR-intervals detected by the smartwatch, matching with the resting ECG recording.

Within this study a one-time baseline measurement will be conducted and there will be no follow-up.

When the patient is present at the outpatient clinic and scheduled for a resting ECG, the smartwatch will start the PPG-recording simultaneously with the ECG-recording. The two simultaneous recordings will be extracted and exported in XML-format and compared on the outcome as described above.

N.A.