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

Completed

• Conditions: Congestive Heart Failure; Cardiac Output, Low; Cardiac Output, High

• Registration Number: NCT04955184
• Lead Sponsor: Biobeat Technologies Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-04
• Study First Submitted QC: 2021-07-04
• Study First Posted: 2021-07-08
• Study Start: 2021-10-10
• Status Verified: 2021-12
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-25
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with CHF

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of cardiac output obtained by a non-unvasive device to the invasive method	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.

Trial Locations

Locations (1)

The Hadassah Ein Kerem Medical Center; 🇮🇱 Jerusalem, Israel