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NCT04955184 Clinical Trial

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

Congestive Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04955184
Other study ID # CO-002-00
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 10, 2021
Est. completion date June 25, 2022

Study information
Verified date December 2021
Source Biobeat Technologies Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date June 25, 2022
Est. primary completion date June 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility Inclusion Criteria: - Patients with CHF Exclusion Criteria: - Pregnant women - Pediatric patients - Inability to sign an informed consent form

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• non-invasive monitoring
non-invasive measurements of cardiac output

Locations
Country Name City State
Israel The Hadassah Ein Kerem Medical Center Jerusalem

Sponsors (2)
Lead Sponsor Collaborator
Biobeat Technologies Ltd. Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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