Necklace-Shaped Sensor for Non-Invasive Monitoring of Stroke Volume and Cardiac Output

Necklace-Shaped Sensor for Non-Invasive Monitoring of Stroke Volume, Cardiac Output, Fluids, Heart Rate, Heart Rate Variability, and Respiration Rate

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02719301

Enrollment

Registered

2016-03-25

Start date

2015-09-30

Completion date

2017-01-31

Last updated

2017-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

Detailed description

Study will compare measurements made with Necklace device for stroke volume/cardiac output with values from a FDA-approved reference device. The gold standard that will be used is Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the Cardiac MRI. Values calculated by the Cardiac MRI analysis will be compared with the reference device and the Necklace. The Cardiac MRI will be received \ 1-4 days after the measurement is completed. The data will be compared with data collected from the Necklace and the reference device during the study.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

* Must be able to undergo Cardiac MRI

Exclusion criteria

* Sensitivity to electrodes

Design outcomes

Primary

Measure	Time frame
Comparison of Stroke Volume Measurement from Necklace with Cardiac MRI measurement of Stroke Volume	Retrospective up to 6 months after study completion

Outcome results