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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04955184
Enrollment
100
Registered
2021-07-08
Start date
2021-10-10
Completion date
2022-06-25
Last updated
2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Non-Invasive Monitoring, Cardiac Output

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.

Interventions

non-invasive measurements of cardiac output

Sponsors

Hadassah Medical Organization
CollaboratorOTHER
Biobeat Technologies Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

* Patients with CHF

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of cardiac output obtained by a non-unvasive device to the invasive method2-4 hours per patientIn 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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026