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

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.