Validation of Ejection Fraction and Cardiac Output Using Biostrap Wristband

Heart Failure Clinical Trial

Official title: A Clinical Validation Study for Measuring Cardiac Output and Ejection Fraction Using a Wrist-worn Device.

Status Recruiting

Clinical Trial Summary

In this study, the investigators will compare the accuracy of the Biostrap wristband, a wearable device with a clinical-grade Photoplethysmography (PPG) sensor, to measure ejection fraction and cardiac output in patients undergoing a cardiac ultrasound and pulmonary arterial catheterization, respectively.

Clinical Trial Description

This in an introductory clinical study with both cardiac patients undergoing elective cardiac ultrasound and cardiac ICU patients with pulmonary arterial catheters featuring Biostrap wristband. This is a single site, non-blinded, non-randomized study. The wristband is a wearable device that contains a clinical-grade Photoplethysmography (PPG) sensor which will measure parameters quasi-continuously and non-invasively. The device, Biostrap wristband, will measure cardiac ejection fraction (EF) and cardiac output (CO). We will enroll a total of 100 patients: 2 groups of 50. 50 patients undergoing an elective cardiac ultrasound as part of their routine medical care will wear the device for 1-2 hours as an outpatient depending on the duration of the test. 50 hospitalized patients with a scheduled or completed pulmonary arterial catheter inserted as part of their standard medical care will wear the device for 7 days.

The investigators will perform a retrospective analysis comparing the accuracy of EF and CO measured by the device in comparison to those from a 'reference device', which is the cardiac ultrasound for ejection fraction and the pulmonary arterial catheter for cardiac output values. Cardiac Ultrasound and pulmonary arterial catheters are standard of care procedures. ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT05279066
• Study type: Observational
• Source: University of California, Los Angeles
• Contact: Suzan Khalil
• Phone: 3102676957
• Email: skhalil@mednet.ucla.edu
• Status: Recruiting
• Start date: March 15, 2022
• Completion date: July 15, 2022