Data Collection Study Using CS BP Pillow System

Completed · Not applicable

Conditions studied: Blood Pressure Monitoring

In brief

Collect raw data from CS BP Pillow System ,CS BP Plate System, IR (Infrared) PPG (Photoplethysmography) sensors and Arterial line (A-line) in volunteers. The data collected in the study will be used for development of the CS BP algorithms.

Key facts

Study ID

NCT07635602

Run by

CardiacSense Ltd.

People needed

50

Starts

2026-02-10

Expected to finish

2026-04-30

Last updated by the study team

2026-08-04

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 20-80 years old.
• Ability and willingness to sign and understand an informed consent form.
• The participant has a palpable radial pulse in both wrists.
• The participant is willing and able to be fitted with the investigational device, A-line, and reference cuff, and is willing and able to undergo all study procedures, including 1 hour of recording with the investigational device and A-line.
• The participant was fitted with both CS BP Plate System devices (one for each hand) and CardiacSense technician has determined the measurement quality to be sufficient.

You may not qualify if…

• Participant who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the participant or interfere with the data collected.
• Participant whose body habitus precludes them from wearing the investigational device on their wrists.
• Female participants who self-reported as pregnant based on a urine pregnancy test, or who are self-reported as trying to get pregnant or who are breastfeeding.
• Participant whose BMI is greater than 35.
• Participant with a documented medical history of cardiac arrhythmia.
• Participant with diagnosed diabetes mellitus.
• Participant with implanted cardiac defibrillators or pacemakers, Ventricular Assist Device (VAD) or other mechanical circulatory support devices, whether intracorporal or extracorporeal.
• Participant with stage 4 or stage 5 end-stage renal disease, or participants with arteriovenous shunts.
• Participant with pheochromocytoma or primary hyperaldosteronism.
• Participant with diagnosed heart failure with New York Heart Association (NYHA) class III/IV, or participants with a history of stroke.
• Participant with a known clotting disorders or currently taking a prescription anticoagulants (daily aspirin use is permitted).
• Participant with an infection requiring antibiotics.
• Participant with peripheral artery disease
• Participants with compromised circulation, including Raynaud's syndrome.
• Participant has a fracture, severe trauma, or anatomical deformity involving the wrist intended for placement of the investigational devices, which could interfere with proper fitting or function of the devices.
• Participant with moderate to severe valvulopathies.
• Participant with primary vasculitis.
• Participant with tremors or otherwise unable to remain still for 1 hour.
• The left to right arm lateral difference of the average systolic blood pressure values is more than 15 mmHg or the lateral difference of the average diastolic blood pressure values is more than 10 mmHg.

Where it is running

• Element Boulder Avista Adventist Hospital Plaza — Louisville, Colorado, United States

Full record on ClinicalTrials.gov

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