Actively Recruiting
Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor
Led by Sky Labs · Updated on 2025-06-15
50
Participants Needed
1
Research Sites
38 weeks
Total Duration
On this page
Sponsors
S
Sky Labs
Lead Sponsor
S
Samsung Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study aims to evaluate the accuracy of the CART BP, a medically approved ring-type blood pressure monitor, in comparison to the traditional auscultatory method using a dual-head stethoscope. The comparison is conducted in accordance with the 2023 European Society of Hypertension (ESH) Recommendations, focusing on patients with suspected hypertension or hypotension. The evaluation includes accuracy measurements across various postures and during different exercise periods.
CONDITIONS
Official Title
Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects aged 18 years or older but younger than 80 years
- Individuals who voluntarily decide to participate in this clinical trial and provide written consent to the information and consent form
- Individuals willing to comply with the clinical trial protocol
You will not qualify if you...
- Subjects who do not consent to the study
- Obese individuals with a Body Mass Index (BMI) of 30 or higher
- Patients or volunteers who are pregnant
- Patients or volunteers with underlying heart diseases such as hospitalization for heart failure, valvular disease, or myocardial infarction
- Patients or volunteers diagnosed with atrial fibrillation on a 12-lead electrocardiogram (ECG) within the past 6 months
- Patients or volunteers with end-stage renal disease undergoing dialysis
- Patients or volunteers unable to perform repeated exercises required for the study
- Patients or volunteers with a systolic blood pressure exceeding 160 millimeters of mercury
- Patients or volunteers with a systolic blood pressure exceeding 160 millimeters of mercury and/or diastolic blood pressure exceeding 100 millimeters of mercury for exercise tests
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
Research Team
G
Gerrard Kim
CONTACT
Y
Yujung Kang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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