(Hyper)tension (High) blood pressure
Conditions
Interventions
The Corsano CardioWatch 287-2 will be investigated in this study. 
 
The CardioWatch 287-2 is a remote monitoring device intended for continuous and spot measurements collection of physiological data in home and healthcare settings. This includes heart rate, heart rate
activity are FDA cleared. 
The Corsano CardioWatch 287-2 System is a Remote-Patient Monitoring System that consists of a monitoring bracelet device worn on the wrist by adult patients (aged 22 years old and over), a web-based b
Vital signs data both on mobile devices and web-based dashboard are available to the HealthCare Provider only. 
Sponsors
Corsano Health B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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 4 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. Applicable for group B: Participant must be over 50 years of age.
Exclusion criteria
Exclusion criteria: 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.Participants suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest > 120bpm) and atrial fibrillation.Participants suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR < 60mL / min / 1.73 m2), hyper- / hypothyroidism, pheochromocytoma or arteriovenous fistula.Participants with known aortic arch pathology or prior surgical intervention involving the aortic arch or descending aorta (e.g., coarctation repair, vascular grafting, or stenting), which may interfere either with accurate peripheral blood pressure measurement. A wrist circumference below 14 cm or above 23 cm.An upper arm circumference < 22cm or > 42cm.Any subject that, in the opinion of the investigator, does not exhibit any phenotype relevant to the objectives of this study (i.e. to ensure all sub-groups have adequate representation).Any condition or circumstance that, in the opinion of the investigator, may preclude study completion, interfere with accurate data collection, bias the results, by instance a subject presenting a lateral Blood Pressure difference at screening of more than 15 mmHg for the systolic and/or more than 10 mmHg for the diastolic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bias and limits of agreement between blood pressure measured by the Corsano CardioWatch 287-2 and blood pressure measured by conventional auscultation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Usability of the Corsano CardioWatch 287-2 in a remote care setting. | — |
Countries
Netherlands, South Africa, United States
Contacts
Public ContactE Ferraris
Corsano Health B.V.
Outcome results
None listed