Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSky Labs
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Subjects who do not consent to the study
Obese individuals with a Body Mass Index (BMI) of 30 or higher (concerns about measurement errors as the standard 24-hour ambulatory blood pressure monitor cuff may not fit the arm properly)
Patients or volunteers who are pregnant
Patients or volunteers with underlying heart diseases: those with a history of hospitalization for heart failure, valvular disease, or myocardial infarction
Trial design
Treatments tested in this trial
- CART BP
- sphygmomanometer
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Sky Labs
Lead sponsor
Samsung Medical Center
Collaborator
Source ClinicalTrials.gov