Validation of Ejection Fraction and Cardiac Output Using Biostrap Wristband

Last updated: March 3, 2022
Sponsor: University of California, Los Angeles
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Chest Pain

Heart Failure

Treatment

N/A

Clinical Study ID

NCT05279066
21-001030
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ≥ 18 years of age.
  2. Subjects who are undergoing elective cardiac ultrasound as an outpatient for group 1or are scheduled for/completed a pilmonary arterial catheterization for group 2.
  3. Written informed consent obtained from subject and ability for subject to comply withthe requirements of the study.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 100
Study Start date:
March 15, 2022
Estimated Completion Date:
July 15, 2022

Study 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.

Connect with a study center

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California 90095
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.