Comparing Cardiac Output Measurements Using a Wearable, Wireless, Non-invasive PPG-Based Device to a Swan Ganz Catheter

Comparing Cardiac Output Measurements Using a Wearable, Wireless, Non-invasive PPG-Based Device to a Swan Ganz Catheter During Ambulatory Assessment of CHF Patients

Invasive pulmonary capillary wedge pressure measurements using a Swan-Ganz catheter (SGC) is considered the gold standard for cardiac output (CO) monitoring. In this prospective study, we will compare CO measurements between a PPG-based wearable monitor and a SGC in ambulatory CHF patients.

Study Overview

• Status: Completed
• Conditions: Congestive Heart Failure; Cardiac Output, Low; Cardiac Output, High
• Intervention / Treatment: Device: non-invasive monitoring

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • The Hadassah Ein Kerem Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients from both sexes with CHF arriving for an ambulatory assessment using a Swan-Ganz catheter in the Medical Center's Cath-lab.

Description

Inclusion Criteria:

• Patients with CHF

Exclusion Criteria:

• Pregnant women
• Pediatric patients
• Inability to sign an informed consent form

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of cardiac output obtained by a non-unvasive device to the invasive method	In each participant, a Swan-Ganz catheter will be inserted as part of their routine assessment, and cardiac output measurements will be compared with a non-invasive wearable and wireless PPG-based device.	2-4 hours per patient

Collaborators and Investigators

• Sponsor: Biobeat Technologies Ltd.
• Collaborators: Hadassah Medical Organization
• Investigators: Principal Investigator: Dean Nachman, MD, The Institute for Research in Military Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2021
• Primary Completion (ACTUAL): June 15, 2022
• Study Completion (ACTUAL): June 25, 2022

Study Registration Dates

• First Submitted: July 4, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (ACTUAL): July 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Cardiac Output; Non-Invasive Monitoring
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Cardiac Output, Low; Cardiac Output, High
• Other Study ID Numbers: CO-002-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We aim to publish the results of this study in a peer-reviewed journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No