Recruiting

Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor

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.

ClinicalTrials.gov IDNCT06513975

PhaseNA

Enrollment50

SponsorSky Labs

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Blood Pressure, Hypertension, Blood Pressure, High, Blood Pressure, Low, Hypotension

About this study

Interventions

Device: CART BP — A ring-type medical device worn by the subject that non-invasively measures systolic and diastolic blood pressure, as well as pulse rate.
Device: sphygmomanometer — Blood pressure measurement method utilizing a two-headed stethoscope, allowing two observers to simultaneously hear the Korotkoff sounds.

Primary outcomes

Mean error and standard deviations of differences between CART BP and Reference (1 hour)

Eligibility information

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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 (SBP) exceeding 160 millimeters of mercury (mmHg) * Patients or volunteers with a systolic blood pressure (SBP) exceeding 160 millimeters of mercury (mmHg) and/or a diastolic blood pressure (DBP) exceeding 100 millimeters of mercury (mmHg) (for exercise tests)

Study locations

Samsung Medical Center, Seoul, South Korea

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.