Data Collection Study Using CS (CardiacSense) BP (Blood Pressure) Watch and Pillow Systems

NCT07749963 | Recruiting FDA Device

• 1 other identifier: 028_BP_DC_US
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Collect raw data from CS Watch System, CS BP Pillow System, Arterial line (A-line) and auscultatory cuff measurements in volunteers. The data collected in the study will be used for development of the CS BP algorithms.

Conditions

Blood Pressure Monitoring

Keywords

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Number of subjects with complete protocol-defined multi-modal physiological signal acquisition

  The primary outcome measure is the number of subjects with complete protocol-defined multi-modal physiological signal acquisition. Multi-modal physiological signal acquisition includes simultaneous recording of: (i) photoplethysmography (PPG); ii) single lead electrocardiography (ECG); iii) tonometry signals from the investigational BP Pillow System ; (iv) continuous invasive arterial blood pressure signals.

  day 1, 1 hour

Study Arms (1)

CS BP Watch System and CS BP Pillow System

EXPERIMENTAL

Data collected from the CS BP Watch and Pillow Systems will be compared to data collected from Arterial Line and auscultatory BP cuff measurements

Device: CS BP Watch and CS BP Pillow Systems

Interventions

CS BP Watch and CS BP Pillow Systems DEVICE

The CS BP Watch System is a wrist-worn data acquisition system designed to estimate BP from time-synchronized ECG and PPG signals. The CS Pillow System estimates BP using a combination of ECG and tonometry signals. The system is comprised of a tonometry-based sensor which is embedded in a biocompatible "pillow" for improved sensitivity and comfort. The Pillow is placed over the pulsatile area of the radial artery using a wristband. Data collected using the CS Watch and CS Pillow Systems will be compared to data collected using Arterial Line and auscultatory BP cuff measurements

Also known as: Arterial Line

CS BP Watch System and CS BP Pillow System

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 devices, A-line, and reference cuff, and is willing and able to undergo all study procedures, including 1 hour of recording with the investigational devices and A-line.
• Participant has good signal quality with the CS Pillow at both wrists.
• Participant has good PPG signals in both thumbs.
• Participant has good ECG signals using the Watch.

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 who has previously participated in a BP study conducted by CardiacSense.
• Participant whose body habitus precludes them from wearing the investigational devices.
• 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 or if arrhythmia was detected during the screening.
• 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 autonomic dysfunction (such as orthostatic hypotension or neuropathy).
• Participant with peripheral artery disease

Sponsors & Collaborators

• CardiacSense Ltd.: lead

Study Sites (1)

Element Boulder Avista Adventist Hospital Plaza

Louisville, Colorado, 80027, United States

RECRUITING

MeSH Terms

Interventions

Vascular Access Devices

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Central Study Contacts

Amarel Boss

CONTACT

+972(54)7970016; amarel@cardiacsense.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 6, 2026
• Study Start: July 21, 2026
• Primary Completion: August 30, 2026
• Study Completion: August 30, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-08

Locations

US (1)