NCT02719301

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
• Phase: —
• Study type: Observational
• Enrollment: 85 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Heart Failure

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2016-03-25
• Last updated: 2017-07-02