Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT05279066

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Biostrap Wristband

Study Details

Brief 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.

Conditions

Heart Failure

Study ID

NCT05279066

Start date

Mar 15, 2022

Status verified date

Mar, 2022

Completion date

Jul 15, 2022

Anticipated

Primary completion date

Jul 15, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients scheduled to undergo an elective cardiac ultrasound

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.

Patients with a pulmonary arterial catheterization scheduled or completed

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.

Interventions

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.

Primary outcome measure

  • Association between obtained PPG waveforms and recorded ejection (EF) fractions [ Time Frame: 6 months ]
  • Association between obtained PPG waveforms and recorded cardiac outputs (CO) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Suzan Khalil

3102676957skhalil@mednet.ucla.edu

Locations

Ronald Reagan UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Suzan Khalil, MD

310-267-6957skhalil@mednet.ucla.edu

Principal Investigator:

Ali Nsair, MD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Mar 15, 2022

Last verified

Mar, 2022

Keywords

  • ejection fraction
  • cardiac output

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2022-03-15.