Cardiac Output, LowNCT04955184
Comparing Cardiac Output Measurements Using a Wearable, Wireless, Non-invasive PPG-Based Device to a Swan Ganz Catheter
An observational study of Cardiac Output, Low and Cardiac Output, High, run by Biobeat Technologies Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Cardiac Output, Low, Cardiac Output, High, Congestive Heart Failure
- What is being tested?
- non-invasive monitoring
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Oct 2021to 25 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with CHF
Who cannot join
- Pregnant women
- Pediatric patients
- Inability to sign an informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- non-invasive monitoring
- Keywords
- Non-Invasive Monitoring, Cardiac Output
- Medical subject headings
- Cardiac Output, Low, Cardiac Output, High, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive monitoringDevice
non-invasive measurements of cardiac output
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-4 hours per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start10 Oct 2021
- Primary completion15 Jun 2022
- Study completion25 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Output, LowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biobeat Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Responsible party
- Sponsor
- Investigators
- Dean Nachman, MD, Principal investigator, The Institute for Research in Military Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955184
- Sponsor's protocol ID
- CO-002-00
- Status last verified
- Dec 2021
- First submitted
- 4 Jul 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: We aim to publish the results of this study in a peer-reviewed journal.
Publications
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.
PubMed 40845743
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Cardiac Output Measurements Using a Wearable, Wireless, Non-invasive PPG-Based Device to a Swan Ganz Catheter During Ambulatory Assessment of CHF Patients
- ClinicalTrials.gov ID
- NCT04955184
- Acronym / sponsor ID
- CO-002-00
- Keywords
- Non-Invasive Monitoring, Cardiac Output
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Biobeat Technologies Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 25 Jun 2022 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with CHF
Key exclusion criteria (3 listed)
- Pregnant women
- Pediatric patients
- Inability to sign an informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive monitoringnon-invasive measurements of cardiac output | Device | – |
Primary outcome
Comparison of cardiac output obtained by a non-unvasive device to the invasive method
Time frame: 2-4 hours per patient
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Derived from this study: PubMed 40845743Nachman 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.
- Individual participant dataSharing planned: Undecided. We aim to publish the results of this study in a peer-reviewed journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dean Nachman, MD principal investigator
The Institute for Research in Military Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Output, Low and Cardiac Output, High, run by Biobeat Technologies Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of cardiac output obtained by a non-unvasive device to the invasive method (time frame: 2-4 hours per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04955184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.