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CompletedNCT04955184Updated Jul 20, 2022

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

An observational study in Cardiac Output, Low, Cardiac Output, High and Congestive Heart Failure, sponsored by Biobeat Technologies Ltd.. Completed at 1 site in Israel. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2022-07-20.

Sponsored by Biobeat Technologies Ltd. · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years to 120 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Non-Invasive Monitoring
  • Cardiac Output
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 100 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Biobeat Technologies Ltd. is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • Patients with CHF

Exclusion criteria

Exclusion Criteria:

  • Pregnant women
  • Pediatric patients
  • Inability to sign an informed consent form
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No

Interventions

  • Devicenon-invasive monitoring

    non-invasive measurements of cardiac output

06

What researchers measure

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.

    Time frame: 2-4 hours per patient

07

Study locations

1 site
  • The Hadassah Ein Kerem Medical Center
    Jerusalem, 91120, Israel
08

References and documents

Individual participant data

Plan to share: Undecided — We aim to publish the results of this study in a peer-reviewed journal.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04955184
Lead sponsor
Biobeat Technologies Ltd.
Collaborators
Hadassah Medical Organization
Responsible party
Sponsor
First posted
Jul 8, 2021
Start date
Oct 10, 2021
Primary completion
Jun 15, 2022
Completion
Jun 25, 2022
Last update
Jul 20, 2022

Study contacts

Dean Nachman, MD
principal investigator · The Institute for Research in Military Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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