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

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Baxter

Status

Completed

Conditions

Heart Failure

Study type

Observational

Funder types

Industry

Identifiers

NCT02719301
PERM-IRB-001-CM

Details and patient eligibility

About

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.

Full 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.

Enrollment

85 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Must be able to undergo Cardiac MRI

Exclusion criteria

Sensitivity to electrodes

Trial design

85 participants in 1 patient group

Men/Women between 18 & 85
Description:
Accepting both healthy and non-healthy subjects. A portion of the subjects will have a fluid management issue or heart failure.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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