NCT05279066

Validation of Ejection Fraction and Cardiac Output Using Biostrap Wristband

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Biostrap Wristband	The Biostrap Wristband device is a non-invasive optical sensor that monitors changes in arterial pulse volume using Photoplethysmography (PPG). PPG is frequently used in wearable sensors to detect heart rate as well as other metrics such as heart rate variability (HRV) and respiratory rate. The raw biosignals recorded by the wristband device will be further processed to estimate the ejection fraction and cardiac output.

Timeline

• Start date: 2022-03-15
• Primary completion: 2022-07-15
• Completion: 2022-07-15
• First posted: 2022-03-15
• Last updated: 2022-03-15

Locations

1 site across 1 country: United States