Recruiting

Observational Study

Sponsor:

CardiacSense Ltd.

Code:

NCT07749963

Conditions

Blood Pressure Monitoring

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

CS BP Watch and CS BP Pillow Systems

Study Details

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

Study ID

NCT07749963

Start date

Jul 21, 2026

Status verified date

Aug, 2026

Completion date

Aug 30, 2026

Anticipated

Primary completion date

Aug 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Main Inclusion Criteria:

1. 50-80 years old.
2. Ability and willingness to sign and understand an informed consent form.
3. The participant has a palpable radial pulse in both wrists.
4. 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.
5. Participant has good signal quality with the CS Pillow at both wrists.
6. Participant has good PPG signals in both thumbs.
7. Participant has good ECG signals using the Watch.

Main Exclusion Criteria:

1. 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.
2. Participant who has previously participated in a BP study conducted by CardiacSense.
3. Participant whose body habitus precludes them from wearing the investigational devices.
4. 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.
5. Participant whose BMI is greater than 35.
6. Participant with a documented medical history of cardiac arrhythmia or if arrhythmia was detected during the screening.
7. Participant with diagnosed diabetes mellitus.
8. Participant with implanted cardiac defibrillators or pacemakers, Ventricular Assist Device (VAD) or other mechanical circulatory support devices, whether intracorporal or extracorporeal.
9. Participant with stage 4 or stage 5 end-stage renal disease, or participants with arteriovenous shunts.
10. Participant with pheochromocytoma or primary hyperaldosteronism.
11. Participant with diagnosed heart failure with New York Heart Association (NYHA) class III/IV, or participants with a history of stroke.
12. Participant with a known clotting disorders or currently taking a prescription anticoagulants (daily aspirin use is permitted).
13. Participant with an infection requiring antibiotics.
14. Participant with autonomic dysfunction (such as orthostatic hypotension or neuropathy).
15. Participant with peripheral artery disease
16. Participants with compromised circulation, including Raynaud's syndrome.
17. Participant has a fracture, severe trauma, or anatomical deformity involving the wrist or fingers intended for placement of the investigational devices, which could interfere with proper fitting or function of the devices.
18. Participant with moderate to severe valvulopathies.
19. Participant with primary vasculitis.
20. Participant with tremors or otherwise unable to remain still for 1 hour.
21. Participants with changes to their antihypertensive medication regimen, including initiation, discontinuation, or dose modification, within 30 days prior to enrollment.
22. 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.
23. Participant belongs to a recruitment category that has already been filled, including BMI category, height category, age group, sex, skin tone category, or blood pressure classification group.
24. Participant with contact allergy to ultrasound gel.
25. Participant with prior or known allergies to lidocaine (or similar pharmacological agents, e.g. Novocaine).
26. Participant with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported).
27. Participant with other known health conditions, that might put the participant at risk or might jeopardize the quality of the data collected.
28. Participant that fails the modified Allen's test (Perfusion Index Ulnar/Ulnar+Radial Ratio test) (Ratio < 0.4).

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: CS BP Watch System and CS BP Pillow System

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

Interventions

CS BP Watch and CS BP Pillow Systems

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

Primary outcome measure

  • Number of subjects with complete protocol-defined multi-modal physiological signal acquisition [ Time Frame: day 1, 1 hour ]

Central Contacts and Locations

Central contacts

Locations

Element Boulder Avista Adventist Hospital Plaza

Recruiting

Louisville, Colorado, United States, 80027

Contacts

Principal Investigator:

Monica Rabanal, FNP

More Information

Sponsor

CardiacSense Ltd.

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • Blood Pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CardiacSense Ltd. on 2026-08-11.