Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

NCT07240831 | Recruiting FDA Device

• 1 other identifier: Biobeat_CLP_001
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 5

Brief Summary

This study aims to validate the accuracy and reliability of blood pressure (BP) estimates obtained over 24 hours using a PPG-based chest-patch device compared to the gold standard ambulatory blood pressure monitoring (ABPM) method using an upper arm cuff-based oscillometric BP device, in both hypertensive and normotensive individuals referred by their provider to undergo a 24-hours ABPM for clinical indication. The Awake/Asleep test, which is the primary test recommended for automated wearable cuffless BP devices that are cuff-calibrated (based on the 2023 European Society of Hypertension (ESH) recommendations for the validation of cuffless blood pressure measuring devices), will be conducted in this study. The secondary aim of the study is to assess the feasibility and convenience of the PPG-based device.

Conditions

Blood Pressure; Heart Disease; Hypertension (HTN); Blood Pressure Monitoring

Keywords

BLOOD PRESSURE; BLOOD PRESSURE MONITORING; Hypertension (HTN); CUFFLESS PHOTOPLETHYSMOGRAPHY; PPG; CUFFLESS; vital signs

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  The accuracy and reliability of the PPG-based chest-patch device will be evaluated by comparing its blood pressure measurements with those obtained through the gold-standard upper arm cuff oscillometric ABPM method. Both systolic and diastolic blood pressure values will be assessed.

  24 hours monitoring

Secondary Outcomes (2)

• Secondary Endpoint

  24 hours

• Secondary Endpoint

  24 hours

Other Outcomes (6)

• Other Endpoints (exploratory analyses)

  24 hours

• Other Endpoints (exploratory analyses)

  24 hours

• Other Endpoints (exploratory analyses)

  24 hours

Study Arms (1)

Device: Non-invasive monitoring

EXPERIMENTAL

The study is designed as a prospective, multicenter, single arm, validation study that follows the 2023 European Society of Hypertension (ESH) recommendations for the validation of cuffless blood pressure measuring devices.27 There is no primary hypothesis. The study will validate 24-hours blood pressure monitoring using the investigational FDA-cleared device by comparing the level of agreement with parallel measurements obtained by the gold-standard upper arm. The Awake/Asleep test is the first and primary test recommended for this type of device to assess validity.

Device: Model BB-613WP

Interventions

Model BB-613WP DEVICE

During the study period, participants will undergo standard ABPM monitoring per clinical indication and wear a PPG-based monitor

Also known as: Biobeat Chest-Patch, PPg-based monitor

Device: Non-invasive monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females and Males subjects 18 years or older (from all skin tones/colors)
• Scheduled for ABPM for hypertension screening, evaluation, or management
• Subjects capable of using an application temporarily downloaded (for the duration of the study) on a personal smart phone device or on a device provided by the study sponsor
• Subjects with Atrial fibrillation or Atrial flutter are eligible to participate if standard cuff-based ABPM monitor can capture blood pressure at initialization

You may not qualify if:

• Indication for ABPM is orthostatic hypotension or Postural Orthostatic Tachycardiac Syndrome as indicated on the ABPM referral order
• Any neurological, psychological, or other condition impairing the ability to provide informed consent or participate in the study
• Inability to reliably access the Internet via a smart phone
• Not able to perform standard cuff-based ABPM
• Average absolute difference between the two arms is greater than 15 mmHg for Systolic Blood Pressure (SBP) or greater than 10 mmHg Diastolic Blood Pressure (DBP) during the initialization/calibration phase
• Subjects with known allergy to adhesives or skin patches
• Subjects with solid dark tattoos on the area where the PPG-based device is attached
• Subjects who are unwilling to have their chest hair shaved, if needed, to install the device (the device uses adhesives and needs to be in direct contact with the skin without hair)
• Subjects who are unwilling to comply with the study instructions (avoid vigorous exercise and showering for 24 hours while the device is in place)

Sponsors & Collaborators

• Biobeat Technologies Ltd.: lead

Study Sites (5)

Cardiology, P.C.

Birmingham, Alabama, 35211, United States

NOT YET RECRUITING

Mayo Clinic

Scottsdale, Arizona, 85259, United States

ACTIVE NOT RECRUITING

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

U Health-University of Miami Health System

Miami, Florida, 33136, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Heart Diseases; Hypertension

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Vascular Diseases

Study Officials

• Ziad Zoghby, M.D., M.B.A.

  Mayo Clinic College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruth Caspi-Molad, M.S.c

CONTACT

+972546969474; ruthie.caspi@bio-beat.com

Study Design

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

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: November 21, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: May 6, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)