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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05279066
• Other study ID #: 21-001030
• Status: Recruiting
• Start date: March 15, 2022
• Est. completion date: July 15, 2022

Study information

• Verified date: March 2022
• Source: University of California, Los Angeles
• Contact: Suzan Khalil
• Phone: 3102676957
• Email: skhalil[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. = 18 years of age.

2. Subjects who are undergoing elective cardiac ultrasound as an outpatient for group 1 or are scheduled for/completed a pilmonary arterial catheterization for group 2.

3. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

1. Subject is unable or unwilling to wear the wristband for the required duration.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between obtained PPG waveforms and recorded ejection (EF) fractions	Patients scheduled to undergo a cardiac ultrasound will wear the Biostrap wristband for the duration of the echocardiogram (1-2 hours) and a PPG waveform will be obtained from the device. The ejection fraction (measured in units of %) will also be obtained from the echocardiogram report. Then, the Artificial Intelligence (AI) staff member will do a predictive model to try and estimate the EF based on the PPG waveform. PPG-derived outcome measures will be derived from a two-step process of raw data collection followed by application of waveform derivative algorithms. They will perform an in-depth beat shape analysis of the PPG waveform that includes identifying dozens of features and critical points of each beat to derive the Ejection fraction (calculated in units of %).	6 months
Primary	Association between obtained PPG waveforms and recorded cardiac outputs (CO)	Patients scheduled to undergo a pulmonary arterial catheterization in the cardiac ICU will wear the biostrap wristband for 7 days and a PPG waveform will be obtained from the device. The cardiac output values (measured in units of mL and recorded using the PA catheter) will also be obtained from the patient's medical record. Then, the Artificial Intelligence (AI) staff member will do a predictive model to try and estimate the CO based on the PPG waveform. PPG-derived outcome measures will be derived from a two-step process of raw data collection followed by application of waveform derivative algorithms. They will perform an in-depth beat shape analysis of the PPG waveform that includes identifying dozens of features and critical points of each beat to derive the Cardiac Output (calculated in unites of mL).	6 months