Validation of Ejection Fraction and Cardiac Output Using Biostrap Wristband

University of California, Los Angeles (UCLA) logo

University of California, Los Angeles (UCLA)

Status

Enrolling

Conditions

Heart Failure

Treatments

Device: Biostrap Wristband

Study type

Observational

Funder types

Other

Identifiers

NCT05279066
21-001030

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

Patients scheduled to undergo an elective cardiac ultrasound
Description:
All cardiac patients undergoing an elective cardiac ultrasound as an outpatient at UCLA may be asked to participate in the study. The investigators will identify eligible patients from their medical record. If interested, patients will be consented prior to their scheduled ultrasound.
Treatment:
Device: Biostrap Wristband
Patients with a pulmonary arterial catheterization scheduled or completed
Description:
All patients hospitalized in the cardiac ICU at UCLA with a pulmonary arterial catheterization scheduled or completed may be asked to participate in the study. The investigators will identify eligible patients from their medical record. If interested, patients will be consented during their hospital stay.
Treatment:
Device: Biostrap Wristband

Trial contacts and locations

1

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Central trial contact

Suzan Khalil

Data sourced from clinicaltrials.gov

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