Anonymized Data Collection From the CS6BP and Other Modalities for the Purpose Measurement of Blood Pressure (BPW)

CardiacSense

Status

Unknown

Conditions

Blood Pressure

Treatments

Device: CS6BP watches will be used in the study.

Study type

Interventional

Funder types

Industry

Identifiers

NCT05370066

007_BPW_DC_OS_BP

CL00600 (Registry Identifier)

Details and patient eligibility

About

This study is performed on hospitalized subjects in the Internal Medicine Division. The study is intended for data collection. The data will be obtained from commercially available blood pressure monitors and simultaneously from the CS6BP watch.

Full description

This is a prospective open-label study. Hospitalized subjects from Internal Medicine Division will be measured simultaneously with a commercially available blood pressure monitor and CS6BP watch. Subjects may be measured at the clinic or home up to one month following their discharge from the hospital.

Screening:

PI or delegated physician will confirm the eligibility of subjects. Eligible subjects will sign an informed consent form before any study procedure initiation.

Recording session during hospitalization:

Each subject will undergo up to 15 blood pressure measurement sessions during the hospitalization period. The subject will be connected to the CS6BP device and a cuff simultaneously during the session. There will be at least 30 minutes intervals between the end of the session to the beginning of the next session.

Recording session during follow-up:

The study team personnel may schedule up to 10 follow-up visits with the subject at the clinic or the subject's home for three months following discharge from the hospital. Up to 3 measurement sessions will be conducted during each follow-up visit, maintaining 30 minutes intervals between sessions.

In case of participant discomfort or mechanical hindrance from the watch, the medical staff will stop data collection. The subject can ask to remove the watch during data collection.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age of eighteen (18) year and above
Ability and willingness to sign an informed consent form

Exclusion criteria

Subjects with hemodynamic support
Subjects receiving more than 2-3 l of fluid per 24h
Subjects with septic shock
Subjects with distal edema
Subjects with arms trauma, where the watch is not wearable
Subjects where the radial artery could not be palpate
Subjects with life expectancy of less than 24h
Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study
Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse, emotional/psychological diagnosis)