The Corsano CardioWatch 287-2 is a medical wearable device that can monitor blood pressure. The device has been validated using clinical trials in hospitals. The aim of this study is to further evaluate blood pressure measurements by the CardioWatch 287-2 in the intended remote setting across various demographic groups.
Primary objective: To assess the difference in blood pressure measurements obtained by the Corsano CardioWatch 287-2 and auscultatory blood pressure monitoring over a period of 31 days.
Secondary objective: To assess the usability of the Corsano CardioWatch 287-2 from a patient perspective.
Participants receiving multiple standardized paired auscultatory and Corsano CardioWatch blood pressure measurements over a 31-day period. The study group will include patients of different ages (above the age of 22 years), genders, and demographics.
Participants must be able to provide informed consent to participate.
Participants must be willing and able to comply with all of the study procedures and return for at least 3 visits.
Participant or witness must be able to read or write in Dutch or English.
Applicable for group A: Participant must be 22 to 50 years of age.
Participants with compromised circulation, injury, or physical malformation of the equipment test sites or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized).
Female participants who are known to be pregnant or who are trying to get pregnant confirmed by a day 1 positive urine pregnancy test unless the study participant is known to be not of child-bearing potential.
Participants with known clotting disorders or currently taking a prescription blood thinner.
Other known health conditions that will prevent safe participation in the study upon disclosure in Health Assessment Short Form or verbally.
The study will involve one patient group (70 patients), visiting the outpatient cardiology clinic at the Reinier de Graaf Gasthuis (NL), one patient group (100 patients) visiting the outpatient clinic of the CENA Research Institute Houston (TX, USA). These demographic groups are both split into group A and B. Group A consists of patients 22 to 50 years of age and group B consists of patients aged 50 years and above.
Cohort
Retrospective
Non-invasive blood pressure measurements with the Corsano CardioWatch 287-2
DeviceNon-invasive blood pressure measurements with the Corsano CardioWatch 287-2 wearable over a period of 31 days.
Auscultatory blood pressure measurement
Diagnostic testAuscultatory blood pressure measurements in supine and sitting position.
Validate blood pressure measurements Corsano CardioWatch 287-2
The main objective of this study is to assess the difference in blood pressure measurements obtained by the Corsano CardioWatch 287-2 and the gold standard auscultatory measurements over a 31-day calibration interval, including evaluation of measurement stability and response to induced blood pressure changes. monitoring over a period of 31 days; to evaluate the performance of the Corsano CardioWatch 287-2.
Assess usability
The secondary objective of this study is to assess the usability of the Corsano CardioWatch 287-2 from a patient perspective in a remote care setting. This will be done by using a questionnaire that assesses the usability, comfort, and noticeability of wearing the CardioWatch 287-2.
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Corsano Health B.V.
Lead sponsor
Reinier de Graaf Groep
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
