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

NCT04955184 | Completed FDA Device

• 1 other identifier: CO-002-00
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Output, Low; Cardiac Output, High; Congestive Heart Failure

Keywords

Non-Invasive Monitoring; Cardiac Output

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

non-invasive monitoring DEVICE

non-invasive measurements of cardiac output

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with CHF

You may not qualify if:

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

Sponsors & Collaborators

• Biobeat Technologies Ltd.: lead
• Hadassah Medical Organization: collaborator

Study Sites (1)

The Hadassah Ein Kerem Medical Center

Jerusalem, 91120, Israel

Location

Related Publications (1)

• Nachman D, Eisenkraft A, Rahamim E, Ibrahimli M, Asenov A, Goldstein N, Kolben Y, Huly S, Ben Ishay A, Fons M, Tabi M, Merin R, Amir O, Asleh R. Assessing Cardiac Flow Measurements Using a Noninvasive Photoplethysmography-Based Device Compared to Invasive Pulmonary Artery Catheter. JACC Adv. 2025 Sep;4(9):102093. doi: 10.1016/j.jacadv.2025.102093. Epub 2025 Aug 22.

  PMID: 40845743 DERIVED

MeSH Terms

Conditions

Cardiac Output, Low; Cardiac Output, High; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dean Nachman, MD

  The Institute for Research in Military Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 8, 2021
• Study Start: October 10, 2021
• Primary Completion: June 15, 2022
• Study Completion: June 25, 2022
• Last Updated: July 20, 2022

Record last verified: 2021-12

Locations

IL (1)