Clinical Trial of Wrist Ambulatory Blood Pressure Monitor in Conformance With the ISO 81060-2:2018+AMD1:2020+AMD2:2024. | NCT07713576

NCT07713576

Overview

NCT ID: NCT07713576
Lead Sponsor: Huawei Device Co., LtdINDUSTRY
Official Title: Clinical Trial on the Effectiveness and Safety of Blood Pressure Function System of Wrist Ambulatory Blood Pressure Monitor
Brief Summary: The accuracy and safety of the Wrist Ambulatory Blood Pressure Monitor (Model: RIV-B10) were assessed according to the requirements of ISO 81060-2:2018+AMD1:2020+AMD2:2024.
Conditions: Blood Pressure
Interventions: Wrist Ambulatory Blood Pressure Monitor/mercury sphygmomanometer

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

Voluntarily participate in this clinical trial and sign informed consent;

Subjects must be willing and able to comply with the study steps;

Subjects aged 18 and above with wrist circumferences of 13.0-21.0 cm.

Exclusion Criteria:

Subjects whose ECG during the screening period showed severe arrhythmias (atrial fibrillation, atrial flutter, ventricular flutter, ventricular fibrillation, ventricular tachycardia, junctional tachycardia, sinus arrest, pathological sinoatrial node syndrome, pacemaker rhythm);

Subjects with sickle cell disease;

Subjects who have undergone previous mastectomy or arm lymph node resection;

Subjects allergic to nylon, fluor rubber, or hydrogenated nitrile rubber (HNBR);

Subjects with wounds on the limbs at the measurement site or inflammation in the wrist;

Subjects undergoing intravenous infusion, blood transfusion, or other catheter insertion at the measurement site of the limb;

Those who ate, drank alcohol, smoked, or exercised vigorously within 30 minutes prior to the study;

Subjects who have participated in other clinical investigations that may affect this trial within the past 30 days;

Investigator believe that subjects should not participate in this clinical trial.