NCT04955184

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

Comparing Cardiac Output Measurements Using a Wearable, Wireless, Non-invasive PPG-Based Device to a Swan Ganz Catheter During Ambulatory Assessment of CHF Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Biobeat Technologies Ltd. · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	non-invasive monitoring	non-invasive measurements of cardiac output

Timeline

• Start date: 2021-10-10
• Primary completion: 2022-06-15
• Completion: 2022-06-25
• First posted: 2021-07-08
• Last updated: 2022-07-20

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated device study