About this trial
Wearable health technology, particularly smartwatches, has revolutionized personal health monitoring by enabling continuous, non-invasive tracking of various physiological parameters. The potential applications of these devices in cardiology are extensive, but it is crucial to validate their accuracy against established medical-grade devices.
The Apple Watch Series 9 (Apple, USA) exemplifies the capabilities of modern smartwatches, offering a wide range of health tracking features. These include heart rate monitoring, detection of irregular heart rhythms suggestive of atrial fibrillation, electrocardiogram recording, blood oxygen level measurement, and comprehensive mobility metrics (including VO2 max, six-minute walk distance, walking speed, step length, double support time, and walking asymmetry). Many of these parameters are highly relevant for cardiovascular patients, potentially aiding in disease progression monitoring and adverse event prediction. However, there is a lack of comprehensive validation studies for these devices in specific cardiovascular disease populations.
This investigator-initiated, prospective observational study will consist of two phases: a training phase which involves 50 participants and a prospective validation phase which involves 20 participants. The study aims to validate smartwatch-based assessments using medical-grade devices and techniques. The study will focus on adult patients with congenital heart disease, pulmonary hypertension, heart failure, and coronary artery disease, as well as athletes undergoing cardiovascular assessment. By comparing smartwatch data with established clinical measurements, we seek to determine the reliability and potential clinical utility of these wearable devices in diverse cardiovascular contexts. Anonymized smartwatch data collected during the two phases will be published to a publicly registry to facilitate further research. This research will help bridge the gap between consumer-grade wearable technology and clinical practice in cardiology.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 20 to 70 years old
Ability to provide informed consent
Adult congenital heart disease
Pulmonary hypertension
Disqualifiers
Contraindication for undergoing physical exertion including cardio-pulmonary exercise testing (CPX) and 6-minute walk test (6MWT)
Pregnancy
Known allergy to components of the investigational product
Trial population
Patients having adult congenital heart disease or pulmonary hypertension, heart failure or coronary artery disease, or are athletes undergoing cardiovascular assessment
Trial design
Case-only
Prospective
Treatments tested in this trial
Apple Watch Series 9
DeviceParticipant will concurrently be wearing the investigational smartwatch for pre- and post-SaO2 and VO2max assessment.
Treatment groups
Trial outcomes
Primary outcomes
Correlation between CPX VO2max and smartwatch parameters (virtual VO2 max, physical activity parameters)
VO2 max (ml/min/kg) concurrently measured with a medical-grade device and a smartwatch which has virutal VO2 max and physical activity parameters as assessed during treadmill exercise
Secondary outcomes
Correlation between VO2 max (ml/min/kg) obtained using medical-grade device and smartwatch
VO2 max (ml/min/kg) obtained using medical-grade device and smartwatch during supervised treadmill exercise
Correlation between SaO2 (%) obtained using medical-grade device and smartwatch
SaO2 (%) obtained using medical-grade device and smartwatch during supervised treadmill exercise
SaO2 (%) measured by the smartwatch
SaO2 (%) measured by the smartwatch during supervised treadmill exercise
SaO2 (%) in participants with severe disease and participants with mild disease
SaO2 (%) in participants with severe versus mild disease during supervised treadmill exercise
Sponsors and contacts
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