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

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

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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

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

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: Subjects requiring 24-hour ambulatory blood pressure monitoringExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Mean error and standard deviations of differences between CART BP and Reference

The primary outcome measure is the mean error and standard deviation (SD) of the differences between the CART BP device and the reference device. This endpoint is determined based on the European Hypertension Society (ESH) recommendation, which states that the pass criteria are as per International Organization for Standardization (ISO) 81060-2:2018: a mean error within 5 mmHg and an standard deviation within ±8 mmHg.

Time frame

1 hour

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sky Labs

Lead sponsor

Samsung Medical Center

Collaborator

Source ClinicalTrials.gov

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