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

NCT ID: NCT04955184

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-10

Study Completion Date

2022-06-25

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Output, Low Cardiac Output, High Congestive Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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non-invasive monitoring

non-invasive measurements of cardiac output

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with CHF

Exclusion Criteria

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

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role collaborator

Biobeat Technologies Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dean Nachman, MD

Role: PRINCIPAL_INVESTIGATOR

The Institute for Research in Military Medicine

Locations

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The Hadassah Ein Kerem Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 40845743 (View on PubMed)

Other Identifiers

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CO-002-00

Identifier Type: -

Identifier Source: org_study_id

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