Atrial Fibrillation.
Gregory F Michaud, William G Stevenson
https://pubmed.ncbi.nlm.nih.gov/33503344Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06508619
Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation Study
Led by Corsano Health B.V. · Updated on 2025-04-20
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
High blood pressure is a common condition that increases the risk of serious cardiovascular problems such as stroke and heart disease. This research is evaluating the Corsano CardioWatch 287-2, a wearable device designed to monitor blood pressure continuously and remotely. The study aims to assess how well this device tracks blood pressure changes after starting or adjusting blood pressure medications over 28 days, compared to standard automatic blood pressure cuffs. Participants will use the Corsano CardioWatch 287-2 bracelet to measure blood pressure continuously during a 28-day period while starting or changing their antihypertensive medication. Blood pressure readings from the wearable device will be compared to those taken by an automatic cuff at the start and end of the study. The device uses optical sensors to measure blood pressure without an inflatable cuff, and this trial focuses on its accuracy in a real-world remote care setting. During the study, patients will wear the CardioWatch 287-2 continuously and perform periodic spot-checks with an automatic cuff. Researchers will collect data on blood pressure before and after medication changes, analyzing the differences between the wearable device and the cuff. The main outcomes measured include average blood pressure changes after 28 days of treatment and the device's ability to track these changes. The study involves adults aged 18 to 80 with uncontrolled hypertension needing treatment adjustments, and participation will last for 28 days.
CONDITIONS
Brief Title
Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation Study
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 80 years old
- Able to provide consent
- Untreated or treated for hypertension with uncontrolled blood pressure
- Medical indication for antihypertensive drug initiation, uptitration, or change per doctor's prescription
You will not qualify if you...
- Unable to wear the Corsano CardioWatch 287-2 due to allergies, wounds, amputations, or similar reasons
- Unable to have blood pressure measured by cuff due to lymphedema, amputation, dialysis shunt, wounds, or similar
- Pregnant women
- Breastfeeding women
- Upper arm circumference outside the cuff range of 22-42 cm
- Unable or unwilling to sign informed consent
- Significant mental or cognitive impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 28 days
Participants receive the Corsano CardioWatch 287-2 device for continuous non-invasive blood pressure monitoring. They perform several spot-checks using an automatic blood pressure cuff as a reference during the start or uptitration of blood pressure lowering medication as part of their standard care.
1 baseline visit and 1 final visit at day 28
Follow-up
Duration - After 28 days
Participants' blood pressure measurements from the Corsano CardioWatch 287-2 are compared with those from the reference automatic blood pressure cuff to assess device accuracy and monitor blood pressure changes over the treatment period.
1 final visit at day 28
Trial Site Locations
Total: 1 location
1
Reinier de Graaf Gasthuis
Delft, South Holland, Netherlands, 2625 AD
Actively Recruiting
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Research Team
M
Marjolein Muller, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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Agnes S Meidert, Bernd Saugel
https://pubmed.ncbi.nlm.nih.gov/29359130Beyond 'failure to rescue': the time has come for continuous ward monitoring.
Daniel I Sessler, Bernd Saugel
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Michael H McGillion, Emmanuelle Duceppe, Katherine Allan...
https://pubmed.ncbi.nlm.nih.gov/29960614The accuracy of heartbeat detection using photoplethysmography technology in cardiac patients.
S Blok, M A Piek, I I Tulevski...
https://pubmed.ncbi.nlm.nih.gov/34256184European Society of Hypertension recommendations for the validation of cuffless blood pressure measuring devices: European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability.
George S Stergiou, Alberto P Avolio, Paolo Palatini...
https://pubmed.ncbi.nlm.nih.gov/37303198